Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-
FDA device recall Z-0864-05 · posted 2005-06-02 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Distribution
- Nationwide and Canada.
- Date initiated
- 2005-02-09
- Date posted
- 2005-06-02
- Date terminated
- 2005-06-29
- Location
- Warsaw, IN
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