Betta Link LG Reusable Fishmouth Guide-Intended for use in soft… — Class II medical device recall Z-2065-2023
Ongoing recall by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., reported 2023-07-12, distributed nationwide. Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential meta
| Recall number | Z-2065-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., GAATON, N/A, Israel |
| Recall initiated | 2023-05-04 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP, NL |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 10818674025833 |
| Lot numbers | 22A01, 22C01, 22F01 |
| Model numbers | 110045157 |
Product
Betta Link LG 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: 110045157
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2065-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.