BETTA LINK SR 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: 110045150
This recall is currently active, issued July 3, 2023. It was issued by T.A.G. Medical Products Corporation, Ltd. Kibbutz Gatton Gaaton Israel.
- Recall Initiated
- May 4, 2023
- Posted
- July 3, 2023
- Recall Number
- Z-2062-2023
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Lot / Code Info
UDI-DI:10818674025802 Lot Numbers: 22A01, 22C01, 22C02, 22F01
Root Cause
Device Design
Action Taken
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.