FDA Device recall Z-2060-2023
BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disrupt…
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disrupt… 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-2060-2023 |
| 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 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
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: 0818674025765 Lot Numbers: 21R01, 21R02, 21R03, 22C02, 22C03, 22C06, 22C08, 22E01, 22E02, 22F01, 22F02, 22F03,…UDI-DI: 0818674025765 Lot Numbers: 21R01, 21R02, 21R03, 22C02, 22C03, 22C06, 22C08, 22E01, 22E02, 22F01, 22F02, 22F03, 22J01, 22J02, 22J03, 22K01, 22K02, 22K03, 22K04, 22K05, 22K07, 22K08, 22K09, 22K10, 22K11, 22M01, 22M02, 22M03, 22M04, 22N01, 22P01, 22P02, 22P03, 22P04, 22P05, 22R01 |
|---|
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-2060-2023%22
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