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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive Reverse Shoulder Instrument Case

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  Class 2 Device Recall Comprehensive Reverse Shoulder Instrument Case see related information
Date Initiated by Firm June 10, 2019
Create Date July 12, 2019
Recall Status1 Terminated 3 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  
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 2		 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.
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