Recall Z-0864-05 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.
| Date | Jun 2, 2005 (initiated Feb 9, 2005) |
| Status | Terminated |
| 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. |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.