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U.S. Department of Health and Human Services

Class 2 Device Recall Coonmad/Morrey

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 Class 2 Recall
Coonmad/Morrey
see related information
Date Posted December 18, 2012
Recall Status1 Terminated on April 17, 2014
Recall Number Z-0537-2013
Recall Event ID 63641
Premarket Notification
510(K) Number
K973357 
Product Classification Prosthesis, Elbow, Constrained, Cemented - Product Code JDC
Product COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.
Code Information Catalog 32-8106-000-03; Lot 61644802
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Roberto Munoz
574-372-4807
Manufacturer Reason
for Recall
Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action Zimmer sent "URGENT MEDICAL DEVICE RECALL" letter dated November 19, 2012 to Distributors, Risk Managers/ Implanting Surgeons, and direct accounts. The notice describes the product, problem, risks and actions to be taken. Consignees were instructed to immediately locate, quarantine and return affected product with the completed Inventory Return Certification form to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 (US accounts) or Zimmer International Logistics GmbH, ATTN: Fao Tanja Herold (Recall Warsaw), Max-Immelmann-Allee 12 79427 Eschbach Germany for international accounts. If an implant is removed from customer inventory, they were directed to provide a copy of the Risk Manager letter upon retrieval of that implant(s) to ensure all facilities are aware of the removal. Surgeons are asked to consider risk information in the letter should a patient present with unexplained symtoms. Hospitals that received direct shipments from the Warsaw Distribution Center will be sent a copy of the Risk Manager letter directly. Questions and concerns along with information on any implanted product is to be addressed to CorporateQuality.PostMarket@zimmer.com using the provided spreadsheet or contact Zimmer at 1-800-447-5633.
Quantity in Commerce 23
Distribution Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JDC and Original Applicant = ZIMMER, INC.
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