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U.S. Department of Health and Human Services

Class 2 Device Recall UltraDrive Irrigation Tubing Assembly

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  Class 2 Device Recall UltraDrive Irrigation Tubing 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-1963-2019
Recall Event ID 83085
510(K)Number K031280  
Product Classification Instrument, surgical, sonic and accessory/attachment - Product Code JDX
Product Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - 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: 211325 209586 210002 210488 210566 210848 210867 210972 211172 211237 212076 212488 212622 212928 212966 214005 214051 214118 214255 214499 214546 214669 214822 214995 215048 215329 215445 215524 215623 216489 216611 217370 217556 217761 217767 218667 219305 219661 219913 220935 
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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