—#65512

Product

Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

FDA product code: HWR — Driver, Prosthesis
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 047367193, 067380510, and 077414021

Why it was recalled

Breakage: breaking of the connecting foot that is on the distal surface of the instrument

Root cause (FDA determination)

Device Design

Action the firm took

The firm notified their distributors of the recall on October 4, 2007, with an Urgent Medical Device Recall letter explaining the problem and requesting return of the product from their inventory and from their consignees. The hospitals were notified of the recall on October 4, 2007 using the same Urgent Device Recall Letter.

Recalling firm

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

Distribution

Distribution pattern: Worldwide-USA and Australia

Timeline

Recall initiated: 2007-10-04
Posted by FDA: 2007-11-27
Terminated: 2009-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65512. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.