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U.S. Department of Health and Human Services

Class 2 Device Recall Coonrad/Morrey total elbow.

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  Class 2 Device Recall Coonrad/Morrey total elbow. see related information
Date Initiated by Firm March 16, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 26, 2004
Recall Number Z-0767-04
Recall Event ID 28576
510(K)Number K001989  
Product Classification Prosthesis, Elbow, Constrained, Cemented - Product Code JDC
Product Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.
Code Information Lot 60039452.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.
FDA Determined
Cause 2		 Other
Action Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.
Distribution United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.
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.
510(K) Database 510(K)s with Product Code = JDC and Original Applicant = ZIMMER, INC.
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