Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046).
FDA Recall Z-1476-06 · Posted 2006-08-31
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2006-08-02
Date Terminated2007-05-04
Product Quantity181 of all devices
Reason for Recall
Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
Firm Action
Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
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.