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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-0091-2008
Recall Event ID 44788
510(K)NumberK953510 
Product Classification hip prosthesis - Product Code KWY
ProductFoundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 624391, 675921, 678791, 678801, 678811, 678821, 679691, 691671, 693931, 693941, 695061, 695921, 696971, 697101, 699941, 208562, 208582, 732861, 733821, 733841, 734401, 735741, 736541, 770141, 773291, 773301, 777461, 779901, 783971, 788521, 794431, 797061, 830311, 831511, 835591, 835601, 842411, 842421, 857791, 872071, 882641, 892391, 892401, 905891, 905901, 907231, 933871, 938271, 958951, 964411, 964421 and 421531A.
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 Commerce304 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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