Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
FDA Recall Z-0867-2007 · Posted 2007-06-07
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeLZO
Date Initiated2007-03-27
Date Terminated2008-06-30
Product Quantity18 units
Reason for Recall
The titanium plasma coating was found to have missing fragments.
Firm Action
The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
Root Cause
Other
Distribution Pattern
Nationwide, Puerto Rico, & Japan
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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