Foundation 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.
FDA Recall Z-0088-2008 · Posted 2007-11-07
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Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeKWY
Date Initiated2007-08-02
Date Terminated2008-01-09
Product Quantity605 units.
Reason for Recall
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Firm 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.
Root Cause
Packaging change control
Distribution Pattern
Worldwide, including USA, Greece, Japan, and Saudi Arabia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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