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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Coonrad/Morrey total elbow cement restrictor

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  Class 2 Device Recall Zimmer Coonrad/Morrey total elbow cement restrictor see related information
Date Initiated by Firm June 08, 2009
Date Posted July 23, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-1700-2009
Recall Event ID 52227
510(K)Number K040389  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800.

Total joint arthroplasy to control, restrict or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Imtramedullary canal must be plugged.
Code Information Lot Numbers: 61249897 and 61249899.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
FDA Determined
Cause 2
Packaging process control
Action Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.
Quantity in Commerce 110
Distribution Worldwide Distribution -- United States, Canada and Japan.
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 = JDI and Original Applicant = ZIMMER, INC.