ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
FDA Recall Z-1064-2007 · Posted 2007-07-23
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJDI
Date Initiated2007-04-12
Date Terminated2007-07-25
Product Quantity3 units.
Reason for Recall
Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
Firm Action
Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
Root Cause
Other
Distribution Pattern
Product distributed to surgical centers in CT, KS and MO.
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.