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Terminated

ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.

FDA Recall Z-1066-2007 · Posted 2007-07-23

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJDI
Date Initiated2007-04-12
Date Terminated2007-07-25
Product Quantity2 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.

K000817OMEGA II MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc. · 2000-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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