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U.S. Department of Health and Human Services

Class 2 Device Recall Maximum Variable Pitch Compression Tray Base

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  Class 2 Device Recall Maximum Variable Pitch Compression Tray Base see related information
Date Initiated by Firm November 28, 2018
Create Date January 14, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-0734-2019
Recall Event ID 81758
Product Classification Tray, surgical, instrument - Product Code FSM
Product Maximum Variable Pitch Compression Tray Base, Reference Number 231201002

Product Usage:
Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
Code Information Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868 
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		 There is a potential for silicone shedding during cleaning and sterilization.
FDA Determined
Cause 2		 Process control
Action Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce 971 i nTotal
Distribution Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
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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