—#53818

Product

Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot No: 60651168 and 60726506.

Why it was recalled

Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound

Root cause (FDA determination)

Process control

Action the firm took

Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E. Main St., Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.

Timeline

Recall initiated: 2007-06-28
Posted by FDA: 2007-12-15
Terminated: 2008-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53818. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.