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U.S. Department of Health and Human Services

Class 2 Device Recall BETTA LINK LG REUSABLE PRONGED GUIDE

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  Class 2 Device Recall BETTA LINK LG REUSABLE PRONGED GUIDE see related information
Date Initiated by Firm May 04, 2023
Date Posted July 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-2064-2023
Recall Event ID 92410
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Part Number: 110045156
Code Information UDI-DI: 10818674025819 Lot Numbers: 22A01, 22C01, 22F01
Recalling Firm/
Manufacturer		 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Kibbutz Gatton
GAATON Israel
For Additional Information Contact SAME
972 49 858400
Manufacturer Reason
for Recall		 Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
FDA Determined
Cause 2		 Device Design
Action Zimmer Biomet issued Alert - Field Safety Notice with TAG Letter to consignees by email. on 5/4/23. Letter states reason for recall, health risk and action to take: 1. Immediately discontinue use, sale and distribution of the above products. 2. Please contact Zimmer Biomet at CorporateQuality.PostMarket@zimmerbiomet.com for questions and clarifications. 3. Our product surveillance specialists are available to answer questions regarding credit for affected devices in your possession. 4. The attached form must be used and sent back immediately. " Complete the Customer Response Form and return it to CorporateQuality.PostMarket@zimmerbiomet.com " Immediately quarantine and return the impacted products to Zimmer Biomet at: Zimmer Biomet Product Service Department ATTN: RECALLS 1777 West Center Street Warsaw, IN 46580 You may direct any questions regarding the recall to CrporateQuality.PostMarket@zimmerbiomet.com.
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Japan, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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