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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 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 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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