—#37435

Product

Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Chisel lot number 60048084.

Why it was recalled

The engraved calibration lines are incorrectly specified, which will result in the user obtaining a reading that the chiseling removed material to a depth 10mm deeper than what was actually removed, thus guiding the user to select a blade plate that is longer than will fit.

Root cause (FDA determination)

Other

Action the firm took

The firm's distribution network was notified via email on 2/9/05, instructed to check their inventory and that of their customer hospitals, and to return the product to Zimmer.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2005-02-09
Posted by FDA: 2005-06-02
Terminated: 2005-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37435. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.