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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Coonrad/Morrey Total Elbow

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  Class 2 Device Recall Zimmer Coonrad/Morrey Total Elbow see related information
Date Initiated by Firm January 30, 2009
Date Posted April 02, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-1058-2009
Recall Event ID 50914
510(K)Number K001989  
Product Classification Prosthesis, elbow, constrained, cemented - Product Code JDC
Product Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-02.

The device is utilized for a total elbow arthroplasty surgical procedure.
Code Information All lots.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall		 The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
FDA Determined
Cause 2		 Labeling design
Action Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.
Quantity in Commerce 14,613 of all products
Distribution Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
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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