Class 2 Device Recall Coonrad/Morrey Elbow Implant System

• Date Initiated by Firm: January 24, 2018
• Date Posted: March 14, 2018
• Recall Status: Terminated 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: 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