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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-0088-2008
Recall Event ID 44788
510(K)NumberK953510 
Product Classification hip prosthesis - Product Code KWY
ProductFoundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 644031, 672331, 677061, 677981, 677991, 678691, 678701, 678711, 678721, 679651, 679661, 697671, 691281, 691291, 693261, 699171, 730241, 735791, 736491, 736501, 736511, 736771, 737811, 738441, 738451, 738461, 770101, 770111, 770221, 773281, 777421, 778431, 782551, 788441, 788451, 810911, 811211, 813501, 830751, 830761, 830911, 830921, 835531, 835541, 842361, 842371, 847411, 848681, 848691, 853541, 857731, 857741, 857751, 875571, 875581, 878371, 878381, 878391, 885381, 885401, 892331, 894241, 894251, 905611, 907121, 907131, 907141, 907211, 925801, 925811, 927241, 927251, 927261, 932761, 949471, 949491, 949851, 951101, 951111, 951121, 958941, 966131, 966141 and 982721.
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 Commerce605 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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