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U.S. Department of Health and Human Services

Class 2 Device Recall INSERT MOBILE "COLLEGIA" TAILLE 5828

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 Class 2 Device Recall INSERT MOBILE "COLLEGIA" TAILLE 5828see related information
Date Initiated by FirmSeptember 05, 2012
Date PostedOctober 31, 2012
Recall Status1 Terminated 3 on January 07, 2014
Recall NumberZ-0183-2013
Recall Event ID 63338
510(K)NumberK003016 K021346 K043073 K052915 K092201 K111698 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductHip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V0821
Code Information INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353  PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V08215433, X01383177, X02394358, X06418357, X07439692, and X08428844 PROFEMUR(R) NECK 8DG A/R LONG, PHA01234, Lot Numbers: X01383179, X02388478, X02396411, X03396412, X04401235, X04401236, X06418358, X06418359, and X07420162  PROFEMUR(R) NECK 15DG A/R SHORT, PHA01242, Lot Numbers: U0366352, V07215735, W12383180, X01388480, X0193876A, X04401237, X04418360, and X06420163  PROFEMUR(R) NECK 15DG A/R LONG, PHA01244, Lot Numbers: U0366343, X01383182, X02388481, X02396414, X03401238, X04410875, X05418362, X06418361, and X07420164 PROFEMUR(R) NECK 8DG VAR/VAL SHORT, PHA01252, Lot Numbers: W11385750, X05418363, and X07418365 PROFEMUR(R) NECK 8DG VAR/VAL LONG, PHA01254, Lot Numbers: V06185863, X01383187, X01385844, X01388485, X04401243, X04401244, X05418366, X06418367, and X07420167  COTYLE "EHS-E" S/CIMENT S/REVET. T.56*41 18 DEG G2, PHA01956, Lot Number: X04396684 INSERT CERAMIQUE 18¿ 28/37G T 28 GROUPE 1 BIOLOX FORTE, PHA02046, Lot Numbers: X02400415, X04427560, X05429759, X07429026, and X10459182 INSERT CERAMIQUE 18¿ 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02052, Lot Numbers: X01383643, X02388588, X02396690, X03401463, X04416678, X05420309, and X05427559 INSERT CERAMIQUE 18¿ 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02058, Lot Numbers: X03416959, X04428692, X06429028, and X09440377 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 1, PHA02246, Lot Numbers: X01383000, X02383646, X03388589, X04396691, and X07420310 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 2, PHA02252, Lot Numbers: X02383647, I X02388433, X03388590, X04396692, X05401465, X07418475, and X07420311 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 3, PHA02258, Lot Numbers: X02388434, X05401466, and X07429040 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 4, PHA02264, Lot Numbers: U0366160, V11289411, and V12289425 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 2, PHA02352, Lot Numbers: X05401467 and X07418477 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 3, PHA02358, Lot Number: X02383648 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G1, PHA02546, Lot Number: X06418478 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G2, PHA02552, Lot Numbers: W01272753, W01289415, W04314279, W12376869, X04396693, X08418479, and X08420314 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G3, PHA02558, Lot Numbers: U0668153, W12378518, X01383651, X03388595, X04396694, and X07418481 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G2, PHA02652, Lot Numbers: X04388596, X04396695, and X05401471 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G3, PHA02658, Lot Numbers: X03396357, X05418482, and X07428694  INSERT CERAMIQUE 18¿ 32/41G T 32 GROUPE 2 BIOLOX FORTE, PHA02852, Lot Numbers: X02388598, X02411905, X03401590, PHA02852, X03411906, X05429029, and X06435536 INSERT CERAMIQUE 18¿ 32/48G T 32 GROUPE 3 BIOLOX FORTE, PHA02858, Lot Numbers: W12389006, W12395616, X0138859, X0139592, X02396697,X03401591, X03411904, and X05418484 INSERT CERAMIQUE 18¿ 32/52G T 32 GROUPE 4 BIOLOX FORTE, PHA02864, Lot Numbers: X01400420, X01402627, X04428395, and X09473192 SHELL SCREW D=5.5 L=15 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02915, Lot Numbers: X02388607, X02396698, X04401592, X04410964, X06428695, andX06429049 SHELL SCREW D=5.5 L=20 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02920, Lot Numbers: X03401593, X04410965, and X06429050 SHELL SCREW D=5.5 L=25 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02925, Lot Numbers: U0370883, U1085036, W04314684, X01383654, X02388609, X03396700, X03401594, X04411243, X10440050, and, X10440392 SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02930, Lot Numbers: X01383007, X04411242, and X06429052, SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02935, Lot Numbers: X01383008, X01383656, X02388611, X03401595, X06429053, and X10441192 SHELL SCREW D=5.5 L=40 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02940, Lot Numbers: V01121498, X01383011, X01383657, X02388602, X04411245, and X06429054 SHELL SCREW D=5.5 L=45 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02945, Lot Numbers: X01383012, X01383658, X02388603, X03396701, and X04411246 SHELL SCREW D=5.5 L=50 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02950, Lot Numbers: X01383013, X02388604, X03396702, X04411247, and X10440396 SHELL SCREW D=5.5 L=55 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02955, Lot Numbers: X01383014, X02388605, and X10440398 SHELL SCREW D=5.5 L=60 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02960, Lot Numbers: X01383015, X02388606, X04401597, X06429055, and X10440399 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 1, PHA02976, Lot Numbers: X04388599 and X04396703 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 2, PHA02978, Lot Numbers: X02383653 and X04388600 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 3, PHA02980, Lot Number: W12372948 INSERT PLAT STANDARD A RETENTION 18 DEG T 32 G 3, PHA02986, Lot Number: X04388601 "PROFEMUR(R) E" HIP STEM SIZE 0 STD, PHA03140, Lot Numbers: U0366209 and U12115660 "PROFEMUR(R) E " HIP STEM SIZE 1 STD, PHA03141, Lot Number: X04396461 "PROFEMUR(R) E " HIP STEM SIZE 2 STD, PHA03142, Lot Numbers: V12300743 and X05401277 "PROFEMUR(R) E " HIP STEM SIZE 4 STD, PHA03144, Lot Number: U0266240 "PROFEMUR(R) E " HIP STEM SIZE 6 STD, PHA03146, Lot Number: V03156768 "PROFEMUR(R) E " HIP STEM SIZE 8 STD, PHA03148, Lot Number: W12383218 "PROFEMUR(R) E " HIP STEM SIZE 9 STD, PHA03149, Lot Numbers: W07334984 and X04401283 "PROFEMUR(R) E" HIP STEM SIZE 1 PLUS, PHA03161, Lot Numbers: W06314259 CRANIAL SCREW L=30 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03202, Lot Numbers: V02137447, W05321360, W05327910, and X03391272 CRANIAL SCREW L=35 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03204, Lot Numbers: W06327911, W10359182, W11372967, X06418488, and X09429068 CRANIAL SCREW L=40 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03206, Lot Numbers: W06335145, W10359183, X03391274, X04396748, and X06420323 CRANIAL SCREW L=45 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03208, Lot Numbers: W04321151, W05327690, W06335146, W11372968, X03376813, X03394306, X04396749, CX06418490, and X09429273 CRANIAL SCREW L=50 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03210, Lot Numbers: X06418491, X06420324, and X09440051 CRANIAL SCREW L=55 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03212, Lot number: X01383605 CRANIAL SCREW L=60 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03214, Lot Numbers: X01383606 and X09440052 FEMORAL STEM "CONTACT E" SIZE 1, PHA03302, Lot Number: X05396734 FEMORAL STEM "CONTACT E" SIZE 4, PHA03308, Lot Number: X03383623 FEMORAL STEM "CONTACT E" SIZE 5, PHA03310, Lot Number: X05388619 FEMORAL STEM "CONTACT E" SIZE 6, PHA03312, Lot Numbers: X01376820, X01378473, X04383625, X04388620, X05418498, and X07420259 FEMORAL STEM "CONTACT E" SIZE 7, PHA03314, Lot Numbers: W08350786, X01383626, X01386652, X04388613, X05418499, and X06420260 FEMORAL STEM "CONTACT E" SIZE 8, PHA03316, Lot Number: X04388614 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10¿ 22*42MM, PHA03604, Lot Numbers: W02317920, W04330182, and W07344145 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10¿ 22*44MM, PHA03606, Lot Numbers: W04330183, W07344146, and X04383554 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10¿ 28*56MM, PHA03618, Lot Numbers: W11376970, W11383159, and X04383560 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10¿ 28*58MM, PHA03620, Lot Numbers: W10350941 and X06428459 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10¿ 28*60MM, PHA03622, Lot Numbers: W04330191 and X04388633 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 44 TP & HAP, PHA04102, Lot Numbers: W02284047, W06321363, and W08334993 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 46 TP & HAP, PHA04104, Lot Number: W08334871 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 52 TP & HAP, PHA04110, Lot Number: W05309202 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 54 TP & HAP, PHA04112, Lot Number: V0385729 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 56 TP & HAP, PHA04114, Lot Numbers: V0385730, W05314708, W06321369, and W08327928 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 58 TP & HAP, PHA04116, Lot Numbers: U1286984, V10204652, W04301081, and W08334997 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 60 TP & HAP, PHA04118, Lot Numbers: U0870001, U0978318, U1186985, V05170004, V07204621, V10204653, V10244023, V11284844, W01257465, W01273565, W04288246, and W10360683 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 62 TP & HAP, PHA04120, Lot Numbers: V12244024, W01257466, W02278812, and W05321371 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 64 TP & HAP, PHA04122, Lot Numbers: U0670005, U1285734, V04153045, V07170006, V07186608, V12244025, and W04278813 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S, PHA04403, Lot Numbers: X01391214, X02391457, X03401202, X03416534, X04420341, X05429760, X05433391, X05433392, X06433393, X10429130, X10441095, X10453674, and X10472722 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M, PHA04404, Lot Numbers: X02391215, X02391458, X02408873, X02408874, X03401203, X04405574, X05419576, X06429131, X07443009, X10445480, X10453230, and X10473195 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L, PHA04406, Lot Numbers: W09376007, X01391216, X02391459, X02408872, X03401204, X04405573, X05433397, X06419577, X06433398, X07443007, X09458368, X09472725, X10429132, X10445479, and X10458369 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S, PHA04408, Lot Numbers: X02391460, X04419578, X05426391, X06443003, X06443004, X09441098, and X10429133  FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M, PHA04410, Lot Numbers: X02401120, X03408539, X05419579, X06420345, X06443001, and X07429134 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L, PHA04412, Lot Numbers: W11385712, X03401173, X10429135, X10441100, and X10453172  FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S, PHA04414, Lot Numbers: X01391188 and X05420347 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L, PHA04418, Lot Number: X10441103 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 S (-4), PHA04465, Lot Numbers: X09441093 and X09441107 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 M (0), PHA04466, Lot Numbers: X02407368, X03413912, X04413915, X05420350, X10441094, and X10441105 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 L (+4), PHA04468, Lot Numbers: X03413910, X03413913, X04413916, and X10441106 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP A, PHA04502, Lot Numbers: X03391192, X03391374, X06429111, X09443000, X10440439, and X10473184 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP B, PHA04504, Lot Numbers: X01391126, X02391375, X05429112, X06440440, and X08453672 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP C, PHA04506, Lot Number: X04405562 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP D, PHA04508, Lot Number: X06440442 RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP G, PHA04514, Lot Numbers: W12383958, X02391131, X03391380, X03405548, X04405565, and X05435509 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0¿ SIZE 28 GROUP B, PHA04604, Lot Numbers: X02391152, X04391416, and X08420330 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0¿ SIZE 28 GROUP C, PHA04606, Lot Numbers: X01391153, X03398168, and X06398204 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0¿ SIZE 32 GROUP D, PHA04608, Lot Numbers: X01391154, X03398169, and X06398205 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0¿ SIZE 32 GROUP E, PHA04610, Lot Numbers: X02391155, X03398170, and X06398206 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0¿ SIZE 36 GROUP F, PHA04612, Lot Numbers: X03398171 and X06398207 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0¿ SIZE 36 GROUP G, PHA04614, Lot Numbers: X01391157, X03398172, and X06398208  RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15¿ SIZE 28 GROUP B, PHA04654, Lot Numbers: X01391159, X06419574, and X06428700 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15¿ SIZE 28 GROUP C, PHA04656, Lot Numbers: X03398173, X04398209, and X08420325 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15¿ SIZE 32 GROUP D, PHA04658, Lot Numbers: X01391161, X03398174, X04398210, X06419575, and X08420326 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15¿ SIZE 32 GROUP E, PHA04660, Lot Numbers: X02391162, X03398175, X05398211, and X08420328 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15¿ SIZE 36 GROUP F, PHA04662, Lot Numbers: X02391163, X03398176, X05398212, X06420074, and X08420329 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15¿ SIZE 36 GROUP G, PHA04664, Lot Numbers: W11383976, X01391164, X03398177, and X06398213 PROFEMUR(R) L HIP STEM SIZE 1 , PHA05502, Lot Numbers: U1187531, V03141654, V07220443, W02288294, W03301272, W05321409, W10359049, X06410992, and X09420103 PROFEMUR(R) L HIP STEM SIZE 2 , PHA05504, Lot Numbers: V04141655, W09359029, W10359380, W11372754, W11376963, X02383508, X03396472, X04401291, and X06410993 PROFEMUR(R) L HIP STEM SIZE 3 , PHA05506, Lot Numbers: X04396473 and X07420105 PROFEMUR(R) L HIP STEM SIZE 4 , PHA05508, Lot Numbers: V04192902 and X04396474 PROFEMUR(R) L HIP STEM SIZE 8 , PHA05516, Lot Numbers: V04141659, W03309102, W05328358, and X02393430 PROFEMUR(R) L HIP STEM SIZE 9 , PHA05518, Lot Numbers: U0674034, U0674036, U0983018, U1177341, U12141640, V04141660, V04150753, V12254742, W02309103, W03309395, W05321415, W07350665, W10359033, W10359387, X01376966, X02383515, X02393431, and X09420111 PROFEMUR(R) L HIP STEM SIZE 10 , PHA05520, Lot Numbers: U0674037, U0677343, U0774038, U1183019, U1287540, V04141661, V04150754, W01288297, W03309104, W05309396, W10372849, W11372762, X01383133, X04383516, X04396330, X04401299, and X10420112 PROFEMUR(R) L HIP STEM SIZE 11 , PHA05522, Lot Numbers: U0674040, U0777345, U0777346, U1283075, U1287541, V01141641, V04141662, V04150755, W03288298, W04301279, W04314911, W05309397, W10372850, X01383517, and X05396480 STEM "PROFEMUR(R) XM" SIZE 0 CR/CO CEMENTED, PHA06000, Lot Number: W12380360 STEM "PROFEMUR(R) XM" SIZE 1 CR/CO CEMENTED, PHA06002, Lot Numbers: W07335073 and W08344355  STEM "PROFEMUR(R) XM" SIZE 2 CR/CO CEMENTED, PHA06004, Lot Numbers: X01380361 and X05398908 STEM "PROFEMUR(R) XM" SIZE 3 CR/CO CEMENTED, PHA06006, Lot Numbers: W11372855 and X05393433 STEM "PROFEMUR(R) XM" SIZE 4 CR/CO CEMENTED, PHA06008, Lot Numbers: W11372856 and X10401304 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.42 GROUP A, PHA06202, Lot Numbers: X03391132, X04391388, and X08418567 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.44 GROUP B, PHA06204, Lot Numbers: X02391133, X03391389, and X06401361 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.46 GROUP C, PHA06206, Lot Numbers: X02391193, X05398958, and X08401620 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.48 GROUP C, PHA06208, Lot Number: W09354559 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.50 GROUP D, PHA06210, Lot Number: X04391392 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.58 GROUP F, PHA06218, Lot Numbers: X05391396 and X07398963 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.60 GROUP G, PHA06220, Lot Numbers: X01383993, X03391220, and X07401659 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.62 GROUP G, PHA06222, Lot Numbers: X01383966, X03391200, X04391397, X05398964, and X07401625 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.64 GROUP G, PHA06224, Lot Numbers: X02391134, X04391398, X06401363, and X07418589 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.66 GROUP G, PHA06226, Lot Numbers: X02391135, X04391399, X06418500, X07401364, and X07418590 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.68 GROUP G, PHA06228, Lot Numbers: X03391136, X04391400, X06401365, and X07418591 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 42 GRP A, PHA06252, Lot Numbers: X05391137 and X10432055 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 44 GRP B, PHA06254, Lot Numbers: X05391138 and X07398190 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 46 GRP C, PHA06256, Lot Numbers: X05391139, X07391139, X07391403, and X07398192 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 58 GRP F, PHA06268, Lot Number: X05391145 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 60 GRP G, PHA06270, Lot Number: X05391146 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 62 GRP G, PHA06272, Lot Numbers: X05391147 and X05391411 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 64 GRP G, PHA06274, Lot Numbers: X05391148, X07391412, and X07398201 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 66 GRP G, PHA06276, Lot Numbers: X05391149, X09398202, and X10391413 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 68 GRP G, PHA06278, Lot Numbers: X05391150 and X09398203 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.42 GROUP A, PHA06402, Lot Numbers: X03391165, X05391429, X06401366, and X10419174 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.44 GROUP B, PHA06404, Lot Numbers: X03391166, X04391430, X05401367, and X10419175 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.46 GROUP C, PHA06406, Lot Numbers: X04391431, X06401373, and X10419176 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.48 GROUP C, PHA06408, Lot Numbers: X05410664 and X06401370 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.50 GROUP D, PHA06410, Lot number: X04391433 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.54 GROUP E, PHA06414, Lot number: X05401371 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.58 GROUP F, PHA06418, Lot number X04398971 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.60 GROUP G, PHA06420, Lot Numbers: X04410179 and X10418603 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.62 GROUP G, PHA06422, Lot Numbers: X02383982, X03391209, X04391439, X04413940, and X06401629 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.64 GROUP G, PHA06424, Lot Numbers: X03391172, X04391440, X06401651, and X10418606 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.66 GROUP G, PHA06426, Lot Numbers: X03391173, X04391441, X06401630, and X10419184 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.68 GROUP G, PHA06428, Lot Numbers: X03391174, X05391442, X06401631, and X10419185 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 42 GRP A, PHA06452, Lot Numbers: X04391175, X05394312, and X05401632 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 44 GRP B, PHA06454, Lot number: X05401633 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 46 GRP C, PHA06456, Lot number: X05401634 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 56 GRP F, PHA06466, Lot number: X05391450 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 58 GRP F, PHA06468, Lot number: W10356967 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 60 GRP G, PHA06470, Lot Numbers: W10356968 and X05410645 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 62 GRP G, PHA06472, Lot Numbers: W10356969, X04383992, and X05401356 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 64 GRP G, PHA06474, Lot Numbers: X04391183, X05391454, and X05401357 CUP "PROCOTYL(R) C" SIZE 56*36 , PHA06612, Lot Number: X03402654 CUP "PROCOTYL(R) C" SIZE 58*36 , PHA06614, Lot Numbers: X03406678 and X05413349 CUP "PROCOTYL(R) C" SIZE 60*36 , PHA06616, Lot Numbers: X03406679 and X05413350 CUP "PROCOTYL(R) C" SIZE 62*36 , PHA06618, Lot Numbers: X03406680 and X05413352 CUP "PROCOTYL(R) C" SIZE 64*36 , PHA06620, Lot Numbers: X03402655 and X05413344 COTYLE "ANCA" SANS TROUS N/REVET. HAP 42, PPR67162, Lot Number: X0419231 COTYLE "ANCA" SANS TROUS N/REVET. HAP 44, PPR67164, Lot Numbers: W02274744, X05437424, X05437426, and X05438571 COTYLE "ANCA" SANS TROUS N/REVET. HAP 46, PPR67166, Lot Numbers: W12359260, X01383050, X04385824, and X04396717 COTYLE "ANCA" SANS TROUS N/REVET. HAP 48, PPR67168, Lot Numbers: X05396718 and X07401501 COTYLE "ANCA" SANS TROUS N/REVET. HAP 50, PPR67170, Lot Numbers: X04385823, X04388622, and X05396719 COTYLE "ANCA" SANS TROUS N/REVET. HAP 52, PPR67172, Lot Numbers: W02278985, W02288422, W07335010, X05401153, and X07401503  COTYLE "ANCA" SANS TROUS N/REVET. HAP 56, PPR67176, Lot Number: U1272106 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 42, PPR67468, Lot Numbers: X06438566, X06438567, X06438835, X06438837, and X06438838 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 44, PPR67470, Lot Numbers: X04117783, X06438569, X06438844, X07401510, and X07449511 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 58, PPR67484, Lot Numbers: X02383055, X05388624, X06396716, and X07420050 INSERT CERAM "ANCA FIT(TM)" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, Lot Numbers: X02400093, X02412719, X09474407, and X09474408 INSERT CERAM "ANCA FIT(TM)" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, Lot Numbers: X02395922, X02406670, X03396561, X03401607, X04420195, X10440215, X10473189, and X10473190 INSERT CERAM "ANCA FIT(TM)" 28/44 56-58/28 AL2.O3 BIOLOX FORTE, PPR67512, Lot Numbers: V06202398, X03388678, X04401608, X04419027, X05428895, X09435512, X10440216, and X10473180 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5D, PPR67600, Lot Numbers: U0670969, U0679765, U0887659, U1280676, W10373028, and W11385761 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5G, PPR67602, Lot Numbers: U0575101, U0672481, U0787660, U1279919, V09244130, V0963602, V11272593, W01300826, W05314775, and X01385762 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11D, PPR67604, Lot Numbers: U0364898, U0887661, U1292236, V04136962, and V09239153 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11G, PPR67606, Lot Numbers: U0568633, U0579766, U0787662, U0872482, U1180679, V04141692, and X10428876 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12D, PPR67608, Lot Numbers: U1296090 and V09244132 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12G, PPR67610, Lot Numbers: X02388726 and X05419035 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13D, PPR67612, Lot Number: W10359266 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13G, PPR67614, Lot Numbers: U1087664 and V10260149 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14D, PPR67616, Lot Numbers: V02132308, V08239159, V10254654, and W03314772 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14G, PPR67618, Lot Numbers: W03309252, W10373036, and X04401521 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15D, PPR67620, Lot Numbers: W04309248 and X09428873 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15G, PPR67622, Lot Numbers: U0368396, U0780692, V02141669, V09215517, W03301156, X01383727, X02388735, X04401523, X05420183, and X06419041 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16D, PPR67624, Lot Numbers: U0975096, V02136969, V0331275, V04156917, V0451269, V07185912, V09273907, V11272599, W01288425, W02301164, W04314333, W09359269, W10373038, W11376877, W11383061, X02383721, X03393461, X04396526, X05420178, and X07428874 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16G, PPR67626, Lot Numbers: U0664915, V0440521, V06202413, V10272600, V11278907, W01288341, W01308058, W0140521, W02301157, W04314780, W11376884, X02388736, and X07420184 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5D, PPR67628, Lot Numbers: U0768644, U0778884, V03185938, V0431283, V09254656, V10281949, W01308060, W01308061, W01308062, W04306670, W09364719, W09374391, W10376707, and X0195958 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5G, PPR67630, Lot Numbers: W01308064, W01308068, W0966209, and X02396549 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 9.5D (POLIE), PPR70000, Lot Number: X0543024110 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11D (POLIE), PPR70004, Lot Number: X04419060 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11G (POLIE), PPR70006, Lot Number: X01388737 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12D (POLIE), PPR70008, Lot Number: X04419062 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12G (POLIE), PPR70010, Lot Numbers: X01388721, X02396846, and X05428441 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13D (POLIE), PPR70012, Lot Numbers: V01121619, X05420170, and X09428857 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13G (POLIE), PPR70014, Lot Numbers: W10373044, X0339651610, X04419065, X05420172, and X09428864 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14D (POLIE), PPR70016, Lot Number: X02388722 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14G (POLIE), PPR70018, Lot Numbers: X04419067 and X05428442 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15D (POLIE), PPR70020, Lot Numbers: X01372772, X04419068, and X05420171 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15G (POLIE), PPR70022, Lot Numbers: X04401538, X04419069, and X05428444 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 17.5 LEFT, PPR72216, Lot Number: X03388712 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 16 RIGHT, PPR72234, Lot Number: X02388703 COTYLE "MULLER" A RETENTION 48*28, PPT01554, Lot Number: X05401328  COTYLE TYPE "MULLER" 44*28 , PPT02000, Lot Numbers: V09187401, W1182815, and X07401331 COTYLE TYPE "MULLER" 50*28 , PPT02300, Lot Number: X07401333 COTYLE TYPE "MULLER" 52*28 , PPT02302, Lot Numbers: X02402650 and X07401334 COTYLE TYPE "MULLER" 54*28 , PPT02400, Lot Number: X06396793 COTYLE TYPE "MULLER" 56*28 , PPT02402, Lot Number: X02402649 COTYLE TYPE "MULLER" 58*28 , PPT02500, Lot Number: X07401337 COTYLE TYPE "MULLER" 60*28 , PPT02501, Lot Number: X01388420 COTYLE TYPE "MULLER" 62*28 , PPT02502, Lot Number: X02402682 TETE FEMORALE 22 CM 12/14 CR/CO (0), PPT07032, Lot Numbers: W12376919, W12383538, X02391324, X04396795, X05396796, X05401639, X09419076, X09420351, X10428704, and X10428705 TETE FEMORALE 22 CL 12/14 CR/CO (+3.5), PPT07034, Lot Numbers: V06215393, W12383540, X01376920, X02391326, X02391327, X04396797, X05401340, X05419077, and X09419078 TETE A JUPE 22 CC 12/14 CR/CO (-3.5), PPT08110, Lot Number: X02383083 TETE A JUPE 22 CL 12/14 CR/CO (+3.5), PPT08114, Lot Number: X02383084 TETE FEMORALE 28 CM 14/16 CR/CO (0), PPT08600, Lot Number: X09440057 TETE FEMORALE 28 CL 14/16 CR/CO (+3.5), PPT08700, Lot Number: X09429157 TETE FEMORALE 28 CC 12/14 CR/CO (-3.5), PPT08710, Lot Numbers: U12116264, X01376909, X02391468, and X05411293 TETE FEMORALE 28 CM 12/14 CR/CO (0), PPT08712, Lot Numbers: X01391328 and X10440481 TETE FEMORALE 28 CL 12/14 CR/CO (+3.5), PPT08714, Lot Numbers: W01288441, X01376914, X01390673, and X05411373 TETE FEMORALE 28 EXL 12/14 CR/CO (+7), PPT08715, Lot Numbers: W10321555, X01383526, and X06391334 TETE FEMORALE 32 CC 14/16 CR/CO (-4), PPT09310, Lot Numbers: X01396350 and X02401177 TETE FEMORALE 32 CL 14/16 CR/CO (+4), PPT09312, Lot Numbers: X01391338, X0219810, X02401179, and X07401346 TETE FEMORALE 32 CC 12/14 CR/CO (-4), PPT09320, Lot Numbers: X01383527, X01391339, and X04396816 TETE FEMORALE 32 CM 12/14 CR/CO (0), PPT09322, Lot Numbers: X01383528, X01391340, and X04396768  TETE FEMORALE 32 CL 12/14 CR/CO (+4), PPT09324, Lot Numbers: X01391341 and X06396769 TETE FEMORALE 32 CC 12/14 CERAMIQUE AL2.O3, PPT10240, Lot Numbers: W12383531, W12395618, X01391483, X02403646, X05429126, X07435527, and X07440466 TETE FEMORALE 32 CM 12/14 CERAMIQUE AL2.O3, PPT10242, Lot Numbers: W12390616, W12395612, X01391484, X02403643, X03410193, X04419084, X05420339, X05426395, and X10445478 TETE FEMORALE 32 CL 12/14 CERAMIQUE AL2.O3, PPT10244, Lot Numbers: W11389001, W12383533, X01403644, X02396819, X02403645, X03410196, X04419085, X05426394, and X09429128 CUPULE MOBILE A BAGUE DE MAINTIEN D=40/22, PPT17000, Lot Numbers: X02383452 and X06421738 CUPULE MOBILE A BAGUE DE MAINTIEN D=43/22, PPT17003, Lot Numbers: V0397724 and X09420214 CUPULE MOBILE A BAGUE DE MAINTIEN D=45/28, PPT17005, Lot number: W05321489 CUPULE MOBILE A BAGUE DE MAINTIEN D=46/28, PPT17006, Lot Numbers: W02301213 and W04321170 CUPULE MOBILE A BAGUE DE MAINTIEN D=49/28, PPT17009, Lot Numbers: X02383457, X06401648, and X09419099 CUPULE MOBILE A BAGUE DE MAINTIEN D=51/28, PPT17011, Lot Numbers: X02383095 and X06419101 CUPULE MOBILE A BAGUE DE MAINTIEN D=52/28, PPT17012, Lot Numbers: X02383478, X03396733, X06401318, and X09419102 CUPULE MOBILE A BAGUE DE MAINTIEN D=53/28, PPT17013, Lot Numbers: X02396373 and X07410931 CUPULE MOBILE A BAGUE DE MAINTIEN D=54/28, PPT17014, Lot Numbers: W12376926, X02383458, X04396724, and X07401319 CUPULE MOBILE A BAGUE DE MAINTIEN D=55/28, PPT17015, Lot Numbers: X03373065, X04396725, X07419105, and X07420226 CUPULE MOBILE A BAGUE DE MAINTIEN D=56/28, PPT17016, Lot Numbers: X0197891A, X03396726, X03408880, X07419106, and X09420227 CUPULE MOBILE A BAGUE DE MAINTIEN D=57/28, PPT17017, Lot Numbers: X06410933 and X07420228 CUPULE MOBILE A BAGUE DE MAINTIEN D=58/28, PPT17018, Lot Numbers: W11344310 and X09420229 CUPULE MOBILE A BAGUE DE MAINTIEN D=59/28, PPT17019, Lot Numbers: X03383459 and X06396727 CUPULE MOBILE A BAGUE DE MAINTIEN D=60/28, PPT17020, Lot Numbers: W06335038, W12383096, and X07419109  VIS A COTYLE D5.5 L=15 "ANCA" , PPV20001, Lot Number: X08440222 VIS A COTYLE D5.5 L=20 "ANCA" , PPV20002, Lot Numbers: W12383687 and X08439698 VIS A COTYLE D5.5 L=25 "ANCA" , PPV20003, Lot Numbers: X01383688, X04401654, X07428902, and X08440224 SCREW FOR "ANCA" SHELL D = 5.5 MM L =30 MM, PPV20004, Lot Numbers: X07428903 and X08440225 VIS A COTYLE D5.5 L=35 "ANCA" , PPV20005, Lot Numbers: X0197339, X02388685, X07428904, and X08440226 VIS A COTYLE D5.5 L=40 "ANCA" , PPV20006, Lot Number: X01383691 VIS A COTYLE D5.5 L=45 "ANCA" , PPV20007, Lot Number: W0681431 VIS A COTYLE D5.5 L=50 "ANCA" , PPV20008, Lot Numbers: W0688950, W1046678, and W1096178 VIS A COTYLE D5.5 L=12 "ANCA" , PPV20010, Lot Numbers: X0435365 and X0440631 STEM REVISION "ULTIME" HA COATED 14/200 LOCKING SCREW D5, PPV80822, Lot Numbers: W01278970, W06309082, W10359026, X02378536, and X04383546 SCREW D5*30 TITANIUM "ULTIME" STEM REVISION, PPV80930, Lot Number: X01383581 SCREW D5*35 TITANIUM "ULTIME" STEM REVISION, PPV80935, Lot Number: X04411255 SCREW D5*40 TITANIUM "ULTIME" STEM REVISION, PPV80940, Lot Numbers: X04411893 and X06429125 SCREW D5*45 TITANIUM "ULTIME" STEM REVISION, PPV80945, Lot Number: X02391353 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00140, Lot Number: X04376678 PROFEMUR(R) STEM EXT 26MM X 21MM DIA, PPW00141, Lot Number: X04376679 PROFEMUR(R) STEM EXT 52MM X 19MM DIA, PPW00144, Lot Number: X04376681 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00148, Lot Number: X03388493 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 10, PPW38000, Lot Numbers: U0465122, U0987554, X04401261, X04409719, X07418377, and X09420118 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 11, PPW38001, Lot Numbers: X03396422, X04401262, and X04409720 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 12, PPW38002, Lot Numbers: X03388501, X03396423, and X05409721 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 13, PPW38003, Lot Number: X03396424 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 14, PPW38004, Lot Numbers: X03388503, X03396425, X05401264, X05409723, and X07420122 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 15, PPW38005, Lot Numbers: X02388504, X02401703, X05409724, X07418382, and X10420123 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 16, PPW38006, Lot Numbers: X03396285, X03396427, and X06401265 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 17, PPW38007, Lot Number: X07418384 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 18, PPW38008, Lot Numbers: X05409725, X06401711, and X07418385 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 19, PPW38009, Lot Numbers: V11292269, X01401721, X02388505, X03396428, X05409726, X06401719, X06401722, and X07418386 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 20, PPW38010, Lot Numbers: W01300721, X04409727, X05100883, and X05401723 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 21, PPW38011, Lot Numbers: V11290488, W12100884, X01401724, X01401726, X05409728, X06401728, and X07418387, PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 22, PPW38012, Lot Numbers: X01401731, X05409729, X06100885, X06100885A, X06401729, and X07418388 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 10, PPW38020, Lot Numbers: X01383191, X02388517, X03396445, X05401266, and X05418389 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 11, PPW38021, Lot Numbers: X02388506, X04396437, X05409730, and X05418390 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 12, PPW38022, Lot Numbers: X01388507, X04409731, X05418391, and X07420124 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 13, PPW38023, Lot Numbers: X05418392 and X10428808 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 14, PPW38024, Lot Numbers: X01388421, X02388509, and X03396440 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 15, PPW38025, Lot Numbers: X02388510 and X03396441 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 16, PPW38026, Lot Numbers: X02388511, X05409733, and X05418395 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 17, PPW38027, Lot Numbers: X02388512, X03396442, and X05418396 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 18, PPW38028, Lot Numbers: X01383194, X02388513, X05409734, X05418397, and X07428418  PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 19, PPW38029, Lot Numbers: V12277782, X01388514, X05409735, and X05418398 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 20, PPW38030, Lot Numbers: V12301619, W10372765, X03388515, X05418399, and X07428419 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 21, PPW38031, Lot Numbers: X05409736 and X05418400 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 22, PPW38032, Lot Numbers: X02388516, X03396443, X03409737, and X05418401 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 10, PPW38040, Lot Numbers: V10271407, W10376686, X01383196, X03396444, X04401258, X05409738, and X09418402 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 11, PPW38041, Lot Numbers: W01287432, X01388487, X03396446, and X06418403 PROFEMUR(R) 215MM STEM BOWED TAPER SIZE 12, PPW38042, Lot Numbers: X01388422, X02388488, and X04409739 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 13, PPW38043, Lot Numbers: X01383197, X02388489, and X06418405 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 14, PPW38044, Lot Numbers: X0284416, X03396449, and X05418406 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 15, PPW38045, Lot Numbers: V12292277, W02300946, X01382943, X01383198, X02388491, X05396450, X05401259, and X06418407 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 16, PPW38046, Lot Numbers: V06227308, W02301470, W11383199, X01388492, X01396451, and X06418408 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 17, PPW38047, Lot Numbers: V12287435, X03418617, X04401260, and X05418409 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 18, PPW38048, Lot Numbers: X03401750, X03401763, X04409743, and X06418410 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 19, PPW38049, Lot Numbers: V11292256 and X05418411 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 20, PPW38050, Lot Numbers: W01111358, X01401765, X03401767, X05418412, and X09420126 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 21, PPW38051, Lot Numbers: X06418413 and X0791110 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 22, PPW38052, Lot Numbers: X01100887A, X0171384, X02397392, X03402993, X04418620, X05409744, and X07418414  "PROFEMUR(R) R" GRIT BLASTED PROX BODY XSMALL, PPW38058, Lot Numbers: V0171443, X03396492, X05401305, X05424421, and X08418416 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 1, PPW38061, Lot Numbers: X0795065.1 and W02112667 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3, PPW38063, Lot Numbers: W02110068 and W0375663 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4, PPW38064, Lot Number: W02110621 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 10.5, PPW38300, Lot Numbers: X04125745, X05409745, and X10420130 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 12, PPW38302, Lot Numbers: X05409746 and X09420131 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 13.5, PPW38304, Lot Numbers: X05396498, X05409747, and X09428420 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 15, PPW38306, Lot Numbers: V06227292, W12382947, W12383200, X03388494, X05100009X1, and X05396499 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 16.5, PPW38308, Lot Numbers: X05396500 and X09428421 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 18, PPW38310, Lot Number: W12382949 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 19.5, PPW38312, Lot Number: X09428422 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 21, PPW38314, Lot Number: X05409748 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 22.5, PPW38316, Lot Numbers: X04125877, X05409749, and X09420132 PROFEMUR(R) 175MM BOWED CYL PS SIZE 10.5, PPW38320, Lot Number: X05409750 PROFEMUR(R) 175MM BOWED CYL PS SIZE 12, PPW38322, Lot Numbers: X03396290, X05396501, and X05409751 PROFEMUR(R) 175MM BOWED CYL PS SIZE 13.5, PPW38324, Lot Numbers: W01300737, X04396502, and X05102041 PROFEMUR(R) 175MM BOWED CYL PS SIZE 15, PPW38326, Lot Numbers: X03396291 and X05396503 PROFEMUR(R) 175MM BOWED CYL PS SIZE 16.5, PPW38328, Lot Numbers: X03396292, X10396504, and X10439998 PROFEMUR(R) 175MM BOWED CYL PS SIZE 18, PPW38330, Lot Numbers: X03382950, X03396293, and X05409752 PROFEMUR(R) 175MM BOWED CYL PS SIZE 19.5, PPW38332, Lot Numbers: X05409753 and X10428423 PROFEMUR(R) 175MM BOWED CYL PS SIZE 21, PPW38334, Lot Numbers: X05409754 and X10428424 PROFEMUR(R) 175MM BOWED CYL PS SIZE 22.5, PPW38336, Lot Numbers: V07100720, X05121256, X05409755, and X10420134 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY X-SMALL MODULAR, PPW38354, Lot number: X09401306 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY SMALL, PPW38360, Lot Number: U1078950 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 1, PPW38361, Lot Number: W12382952 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 2, PPW38362, Lot Numbers: X04396506 and X09401251 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 3, PPW38363, Lot Numbers: X02382954, X04396507, and X08409756 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 4, PPW38364, Lot Numbers: W12382955, X02383204, X02385735, and X05409757 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY LARGE, PPW38365, Lot Number: X05409758 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ10.5, PPW38370, Lot Numbers: U0463053, W01100739, X03396294, and X05409759 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 12, PPW38372, Lot Numbers: X03396295 and X05409760 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 15, PPW38376, Lot Number: X03396297 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ16.5, PPW38378, Lot Numbers: X05409761 and X09428425 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 18, PPW38380, Lot Numbers: X05409762 and X09428426 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ19.5, PPW38382, Lot Numbers: X04125896, X05409763, and X10428427 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ 21, PPW38384, Lot Numbers: X05125897, X05409764, and X10420141 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ22.5, PPW38386, Lot Numbers: X05409765 and X10428428 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SZ 12, PPW38404, Lot Number: X04100973 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38410, Lot Number: X0239629910 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38422, Lot Number: X04409768 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 12, PPW38424, Lot Numbers: W01300738, X04100971, and X04100978 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38430, Lot Numbers: X05100968 and X05409769 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 18, PPW38432, Lot Number: X05409770 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38442, Lot Number: X05410188 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 15, PPW38448, Lot Numbers: X02396302 and X04409773 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 18, PPW38452, Lot Number: X04409774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 19.5, PPW38454, Lot Numbers: X04129583 and X04409775 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 21, PPW38456, Lot Numbers: X04129255, X04409776, and X05425774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 22.5, PPW38458, Lot Number: X04129256 TIGE PROXIM. MONOBLOC V4 EV1 "PROFEMUR(R) R" EX/SMALL, PPW39009, Lot Numbers: U01136593, U0665166, X08401542, and X09419124 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 2 V4, PPW39106, Lot Number : X05401544 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3 V4, PPW39108, Lot Numbers: W06328345, X02388522, X05409779, and X09419155 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4 V4, PPW39110, Lot Numbers: X01385799, X02388523, X03396485, X05401545, and X05409780 "PROFEMUR(R) R" GRIT BLASTED PROX BODY LARGE V4, PPW39112, Lot Numbers: X01383506, X02388524, X04396486, X05401546, and X08409782 "PROFEMUR(R) R" HA COATED PROX BODY SMALL V4, PPW39122, Lot Number: U0980429 "PROFEMUR(R) R" HA COATED PROX BODY STD 1 V4, PPW39124, Lot Number: V11244233 "PROFEMUR(R) R" HA COATED PROX BODY STD 2 V4, PPW39126, Lot Numbers: U1187740 and V11244234 "PROFEMUR(R) R" HA COATED PROX BODY STD 3 V4, PPW39128, Lot Numbers: V05143958, X04396496, and X09419148 "PROFEMUR(R) R" HA COATED PROX BODY STD 4 V4, PPW39130, Lot Numbers: U1180433, V02140197, W11359374, X04396497, X07401247, X09419149, and X09428831 "PROFEMUR(R) R" HA COATED PROX BODY LARGE V4, PPW39132, Lot Numbers: W01278887, W06314895, W07328343, X07401248, and X09419150 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 00, PPX028059, Lot Number: X01350955  FEMORAL STEM "HELIANTHE" COATED HAP SIZE 5, PPX028065, Lot Number: X02388557 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 3, PPX02873, Lot Numbers: X04404311 and X06420279 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 4, PPX02874, Lot Numbers: X03396831 and X05419133 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 5, PPX02875, Lot Numbers: X02383116, X02396342, and X03396832 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 6, PPX02876, Lot Numbers: X04388553 and X04396833  
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information ContactDoug Shufelt
901-867-4655
Manufacturer Reason
for Recall
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
FDA Determined
Cause 2
Packaging process control
ActionWright sent an Urgent Product Recall Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and immediately return to Wright Medical Technology, Inc. Customers were asked to complete and return the enclosed notification form by fax to 901-867-7401. For questions customers should call 901-867-4324. For questions regarding this recall call 901-867-4655.
Quantity in Commerce31,566 units
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LPH
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