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Medical Device Recalls
Class 2 Recall
Foundation® Hip System Bipolar Modular

See Related Information
Date Recall
Initiated		 August 02, 2007
Date Posted November 07, 2007
Recall Number Z-0084-2008
Product Foundation? Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 644021, 648331, 672341, 675901, 678461, 678471, 678481, 678491, 678501, 678511, 678521, 693251, 694501, 697771, 732831, 733871, 736411, 736741, 738071, 738081, 738411, 738421, 770041, 774781, 774791, 777391, 779571, 779581, 783901, 783911, 788351, 794371, 794381, 811151, 811161, 835501, 835511, 836161, 844591, 845951, 848661, 854461, 854471, 854481, 854491, 857681, 874941, 874951, 882561, 882571, 882581, 893551, 893561, 893571, 903121, 903131, 933751, 944241, 944251, 949391, 949401, 964171, 964181, 964191 and 964201.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin , Texas 78758
Reason For
Recall		 Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Action Firm 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 Commerce 382 units.
Distribution Worldwide, including USA, Greece, Japan, and Saudi Arabia.
 

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