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Terminated

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

FDA Recall Z-0864-05 · Posted 2005-06-02

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2005-02-09
Date Terminated2005-06-29

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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