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U.S. Department of Health and Human Services

Class 2 Device Recall Coonrad/Morrey Elbow Implant System

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  Class 2 Device Recall Coonrad/Morrey Elbow Implant System see related information
Date Initiated by Firm January 24, 2018
Date Posted March 14, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-1239-2018
Recall Event ID 79400
510(K)Number K001989  
Product Classification Prosthesis, elbow, constrained, cemented - Product Code JDC
Product Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Code Information Lot Number: 63694912
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 One lot of humeral stem implants do not include the humeral bushing components.
FDA Determined
Cause 2		 Under Investigation by firm
Action 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons.
Quantity in Commerce 9
Distribution Distributed in China and Taiwan.
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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