Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Unicompartmental Knee System headed screw

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Zimmer Unicompartmental Knee System headed screw see related information
Date Initiated by Firm June 30, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on December 17, 2008
Recall Number Z-2300-2008
Recall Event ID 48716
Product Classification cutting guide screw - Product Code LXH
Product Zimmer 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.
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
Action Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.
Quantity in Commerce 5
Distribution Florida, China and India.
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.
-
-