—#42483

Product

Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.

FDA product code: GFG — Bit, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lots 480103, 480104 and 487665.

Why it was recalled

The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via recall letter dated 9/30/05.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia.

Timeline

Recall initiated: 2005-09-30
Posted by FDA: 2005-10-28
Terminated: 2005-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.