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Medical Device Recalls
Class 2 Recall
Foundation® Hip System Bipolar Modular
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Date Recall Initiated |
August 02, 2007
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Date Posted |
November 07, 2007
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Recall Number |
Z-0084-2008
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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.
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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.
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Recalling Firm/ Manufacturer |
Encore Medical, Lp
9800 Metric Blvd
Austin
, Texas
78758
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Reason For Recall |
Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
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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.
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Quantity in Commerce |
382 units.
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Distribution |
Worldwide, including USA, Greece, Japan, and Saudi Arabia.
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