T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Recall 92410
Description: 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
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Recall 92410 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2065-2023 |
| Event ID | 92410 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands. |
| Quantity | N/A |
| Recall 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. |
| Device Classification | 20230712 |
| Device Code Info | UDI-DI: 10818674025833 Lot Numbers: 22A01, 22C01, 22F01 |
| Center Classification Date | 20230703 |
| Recall Initiation Date | 20230504 |
| Recalling Firm | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| Initial Notification | |
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