Date Initiated by Firm |
June 09, 2008 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number |
Z-2179-2008 |
Recall Event ID |
48631 |
Product Classification |
Plate - Product Code HRS
|
Product |
Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process. |
Code Information |
Lot 60985554. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
574-371-8028
|
Manufacturer Reason for Recall |
An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.
|
FDA Determined Cause 2 |
Material/Component Contamination |
Action |
Zimmer Thailand was notified via an emailed letter dated 6/9/08 to check for inventory at all customer accounts and to return the product. Contact Zimmer at 1-574-371-8028 for assistance. |
Quantity in Commerce |
7 |
Distribution |
International Distribution --- including Thailand. |
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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