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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-0093-2008
Recall Event ID 44788
510(K)NumberK953510 
Product Classification hip prosthesis - Product Code KWY
ProductFoundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 542491, 624411, 676831, 678881, 678891, 679701, 690791, 695161, 695931, 735751, 770161, 777481, 777491, 788551, 794441, 814361, 830971, 844631, 844641, 847421, 850801, 854661, 854671, 875521, 875531, 878441, 882651, 882661, 894281, 894291, 905661, 907251, 933901, 949551 and 964471.
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 Commerce185 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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