BETTA LINK SR Reusable Fishmouth Guide may bend and shed metal shavings
T.A.G. Medical Products is recalling BETTA LINK SR Reusable Fishmouth Guides (Part Number 110045151) because the drill guides may bend during surgical use and result in metal shavings. The risk to patients includes potential injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II surgical device recall involving a confirmed structural defect in an active surgical instrument. The drill guides may bend and produce metal shavings during use. No patient injuries have been reported, placing this at High severity per the rubric criterion for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
T.A.G. Medical Products Corporation, LTD. is recalling BETTA LINK SR Reusable Fishmouth Guides (Part Number 110045151). These devices are used in soft tissue to bone fixation during ligament and tendon repair surgeries. Affected devices were distributed nationwide in the United States and also in Australia, Japan, and the Netherlands. The recall includes lot numbers 22A01, 22C01, and 22C02.
During surgical procedures, the drill guides may bend when surgeons apply axial forces with drill equipment. This bending can cause friction between the guide and the drill bit, resulting in potential metal shavings.
Healthcare facilities using the affected devices should contact T.A.G. Medical Products Corporation, LTD. for further instructions. This is a Class II recall.
The recalled product
- Product
- BETTA LINK SR 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: 110045151
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Hazard
- metal-shavings
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 10818674025826 Lot Numbers: 22A01
- 22C01
- 22C02
Distribution
Distributed nationwide across the United States.
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