| Date Initiated by Firm |
February 09, 2005 |
| Date Posted |
June 02, 2005 |
| Recall Status1 |
Terminated 3 on June 29, 2005 |
| Recall Number |
Z-0864-05 |
| Recall Event ID |
31232 |
| Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
|
| Product |
Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10. |
| Code Information |
Chisel lot number 60048084. |
Recalling Firm/
Manufacturer |
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
|
| For Additional Information Contact |
800-846-4637
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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