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U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Unicompartmental Knee System headed screw

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 Class 3 Device Recall Zimmer Unicompartmental Knee System headed screwsee related information
Date Initiated by FirmJune 30, 2008
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on December 17, 2008
Recall NumberZ-2300-2008
Recall Event ID 48716
Product Classification cutting guide screw - Product Code LXH
ProductZimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
Code Information Lot 60954069.
FEI Number 1000220733
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 screw, resulting in breakage and/or surgical delays.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionZimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.
Quantity in Commerce5
DistributionFlorida, China and India.
Total Product Life CycleTPLC 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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