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
Reported: July 12, 2023 Initiated: May 4, 2023 #Z-2065-2023
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.
Details
- Recalling Firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Units Affected
- N/A
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
- Location
- GAATON, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2065-2023.
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