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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/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
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.