—#51727

Product

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

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K003016
Affected lot / code info: Lot No. W09350601

Why it was recalled

The titanium plasma coating was found to have missing fragments.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Road PO Box 100, Arlington, Tennessee 38002-0100

Distribution

Distribution pattern: Nationwide, Puerto Rico, & Japan

Timeline

Recall initiated: 2007-03-27
Posted by FDA: 2007-06-07
Terminated: 2008-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.