Class 2 Device Recall Comprehensive Reverse Shoulder Instrument Case

• Date Initiated by Firm: June 10, 2019
• Create Date: July 12, 2019
• Recall Status: Terminated on September 10, 2020
• Recall Number: Z-1960-2019
• Recall Event ID: 83099
• Product Classification: Tray, surgical, instrument - Product Code FSM
• Product: Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
• Code Information: Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340
• FEI Number: 1825034
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Lack of an adequate sterilization validation.
• FDA Determined Cause: Under Investigation by firm
• Action: Medical Device Recall notification letters dated 6/10/19 were sent to customers.
• Quantity in Commerce: 92
• Distribution: The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, 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.