—#50421

Product

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 60605829.

Why it was recalled

The reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.

Root cause (FDA determination)

Other

Action the firm took

Zimmer sales staff was notified by letter dated 2/1/07 to pull any of the product from stock and to provide the name and address of their hospital customer accounts for further notification by Zimmer.

Recalling firm

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

Distribution

Distribution pattern: California, Ohio and Texas.

Timeline

Recall initiated: 2007-02-01
Posted by FDA: 2007-03-29
Terminated: 2007-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.