Betta Link LG Surgical Guide May Deform and Produce Metal Shavings
Betta Link LG surgical guides used in soft tissue and bone repair may bend under pressure during surgery, potentially releasing metal shavings that could injure patients. The manufacturer is recalling affected units in the U.S. and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II device recall with no reported illnesses or injuries. The hazard is theoretical—potential metal shavings from device deformation during use—without documented cases of patient harm. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
T.A.G. Medical Products Corporation, Ltd. is recalling the Betta Link LG Reusable Fishmouth Guide, a surgical instrument used for soft tissue and bone fixation in ligament and tendon repair or reconstruction surgeries. The affected lot numbers are 22A01, 22C01, and 22F01.
When surgeons apply axial force during surgical procedures, the guide may bend. This deformation can cause friction with the drill bit, producing metal shavings that may be present during surgery and potentially injure patients.
The product was distributed worldwide, including to users in the United States, Australia, Japan, and the Netherlands.
Healthcare facilities and users of affected products should immediately discontinue use of these lot numbers. Contact T.A.G. Medical Products or the FDA for instructions on replacement, inspection, or return of affected guides.
The recalled product
- 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
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
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: 10818674025833 Lot Numbers: 22A01
- 22C01
- 22F01
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
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- HighBETTA LINK SR Knotless Implant Kit Drill Guides May Bend During Surgery
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