Recall Z-2061-2023
T.A.G. Medical Products Corporation, Ltd. · initiated May 4, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BETTA LINK LG KNOTLESS IMPLANT KIT-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: 110045160
Codes / lots: UDI-DI: 10818674025772 Lot Numbers: 21E28, 21R15, 21R16, 21R32, 21R35, 22C19, 22E29, 22F10, 22F35, 22J07, 22J08, 22J09, 22J18, 22J19, 22J27, 22J28, 22J33, 22K23, 22K24, 22K32, 22K33, 22K38, 22M03, 22M04, 22M24, 22P03, 22P09, 22P10, 22P11, 22P13, 22P14, 22P16
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: 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.
Details
- Recall number
- Z-2061-2023
- Initiated
- May 4, 2023
- Posted by FDA
- July 3, 2023
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
- Recalling firm
- T.A.G. Medical Products Corporation, Ltd., Gatton GAATON
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2060-2023 Class II | BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | 05/04/2023Open, Classified |
| Z-2062-2023 Class II | BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | 05/04/2023Open, Classified |
| Z-2063-2023 Class II | BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | 05/04/2023Open, Classified |
| Z-2064-2023 Class II | Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | 05/04/2023Open, Classified |
| Z-2065-2023 Class II | Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation…Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential… | 05/04/2023Open, Classified |