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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Hip System Bipolar Modular

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 Class 2 Device Recall Foundation Hip System Bipolar Modularsee related information
Date Initiated by FirmAugust 02, 2007
Date PostedNovember 07, 2007
Recall Status1 Terminated 3 on January 09, 2008
Recall NumberZ-0085-2008
Recall Event ID 44788
510(K)NumberK953510 
Product Classification hip prosthesis - Product Code KWY
ProductFoundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 679631, 678531, 678541, 678551, 678561, 678571, 691661, 692771, 692761, 694351, 694401, 694411, 694421, 698261, 695131, 695911, 697781, 730131, 731451, 731461, 731471, 205452, 736421, 770051, 770061, 770071, 770181, 780151, 783921, 788361, 792671, 794391, 811171, 811181, 811191, 811201, 811291, 832281, 832291, 835521, 842301, 842311, 848671, 854501, 854511, 854981, 874961, 874971, 874981, 882591, 882601, 893581, 893591, 893601, 893611, 903141, 903151, 905561, 925731, 925741, 925751, 927231, 932711, 932721, 933761, 933771, 933781, 944261, 944271, 949411, 949421, 964211, 964221, 964231 and 964241.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-834-6235
Manufacturer Reason
for Recall		Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
FDA Determined
Cause 2		Packaging change control
ActionFirm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
Quantity in Commerce479 units.
DistributionWorldwide, including USA, Greece, Japan, and Saudi Arabia.
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 = KWY
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