—#45169

Product

Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots 08686700 and 08686500.

Why it was recalled

A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.

Root cause (FDA determination)

Other

Action the firm took

Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.

Timeline

Recall initiated: 2006-02-02
Posted by FDA: 2006-03-21
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.