Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Hazard
Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
What You Should Do
Remedy
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.
Affected by this recall?
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Products
Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
- UPC
- Lot #: 633811, 633851, 738381, 738391, 770021, 777371, 792441, 817581, 831031, 878311, 905531, 905541, 907051, 944231, and 949371.
Units Affected
76 units.