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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 5828 see related information
Date Posted October 31, 2012
Recall Status1 Terminated on January 07, 2014
Recall Number Z-0183-2013
Recall Event ID 63338
510(K)Number K092201  K021346  K043073  K111698  K052915  K003016 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Hip 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 444
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: X0641093
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
901-387-9971
For Additional Information Contact Doug 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
Action Wright 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 Commerce 31,566 units
Distribution Worldwide 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 Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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