FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.
- Recall number
- Z-0864-05
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.
- Status
- Terminated
- Initiated
- 2005-02-09
- Posted
- 2005-06-02
- Terminated
- 2005-06-29
- Reason
- 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
- Other
- 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.
- Quantity
- not on file
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Chisel lot number 60048084.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28