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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-0089-2008
Recall Event ID 44788
510(K)NumberK953510 
Product Classification hip prosthesis - Product Code KWY
ProductFoundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 602731, 677071, 677081, 677091, 678001, 678011, 678731, 678741, 678751, 678761, 693891, 693901, 695101, 697801, 699141, 699151, 732841, 208522, 208532, 208542, 208552, 733961, 734521, 735721, 736521, 739121, 770121, 777431, 780391, 783951, 788491, 796481, 797041, 797341, 814321, 814331, 830931, 830941, 835561, 836181, 842381, 844601, 848701, 853551, 855191, 855201, 857761, 857771, 875591, 875601, 878401, 878411, 878421, 878431, 885391, 892341, 907151, 907161, 907171, 907181, 907191, 907201, 925821, 933801, 933811, 933821, 933831, 949501, 949511, 964361, 964371, 982731 and 421511A. 
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 Commerce478 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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