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Terminated

Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.

FDA Recall Z-0868-2007 · Posted 2007-06-07

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeLZO
Date Initiated2007-03-27
Date Terminated2008-06-30
Product Quantity4 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.

K003016PRO-FEMUR RWrightmedicaltechnologyinc · 2000-12-13

Official Source

View FDA Recall →

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

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