Recall Z-2065-2023— T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Class II · Ongoing
Class II FDA medical device recall by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD., initiated 2023-05-04. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-04
- Firm location
- GAATON, N/A, Israel
Product 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.