Date Initiated by Firm |
February 01, 2007 |
Date Posted |
March 29, 2007 |
Recall Status1 |
Terminated 3 on May 04, 2007 |
Recall Number |
Z-0675-2007 |
Recall Event ID |
37365 |
Product Classification |
shoulder implant instrumentation - Product Code LXH
|
Product |
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00. |
Code Information |
Lot 60605829. |
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 reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
|
FDA Determined Cause 2 |
Other |
Action |
Zimmer sales staff was notified by letter dated 2/1/07 to pull any of the product from stock and to provide the name and address of their hospital customer accounts for further notification by Zimmer. |
Quantity in Commerce |
4 |
Distribution |
California, Ohio and Texas. |
Total Product Life Cycle |
TPLC Device Report
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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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