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U.S. Department of Health and Human Services

Class 2 Device Recall UltraDrive Hose/Drape Assembly

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  Class 2 Device Recall UltraDrive Hose/Drape Assembly see related information
Date Initiated by Firm June 04, 2019
Create Date July 12, 2019
Recall Status1 Terminated 3 on July 21, 2021
Recall Number Z-1962-2019
Recall Event ID 83085
510(K)Number K031280  
Product Classification Instrument, surgical, sonic and accessory/attachment - Product Code JDX
Product Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Code Information Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825 
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		 The products do not have sufficient data to support the labeled shelf life of 10 years.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.
Quantity in Commerce 8478 total
Distribution Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, 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 = JDX and Original Applicant = BIOMET, INC.
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