Recall Z-2060-2023 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
BETTA LINK SR 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:110045154
| Date | Jul 3, 2023 (initiated May 4, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 i |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210498 | Betta Link Knotless Implant System T.A.G. Medical Products Corporation, Ltd., Mar 24, 2021 |