FDA Device recall Z-2063-2023
BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon dis…
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon dis… by T A G Medical Products, citing 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 includ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2063-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-04 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | T A G Medical Products |
| Distribution | US |
Product
BETTA LINK SR REUSABLE FISHMOUTH 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: 110045151
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.
Identifiers
| code_info | UDI-DI: 10818674025826 Lot Numbers: 22A01, 22C01,22C02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2063-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.