Surgical drill guides may bend and produce metal shavings during use
T.A.G. MEDICAL PRODUCTS CORPORATION is recalling Betta Link LG Reusable ProngED Guides used in orthopedic surgery because the guides may bend when force is applied, creating metal shavings that could injure patients.
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: This is an FDA Class II recall involving a surgical instrument that may malfunction during use. No illnesses or injuries have been reported, but the device poses a theoretical risk of patient injury through metal fragment generation. This falls within the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. is recalling the Betta Link LG Reusable ProngED Guide (Part Number 110045156), a medical device used in soft tissue to bone fixation during repair of ligament or tendon disruption or reconstruction surgeries.
The drill guides may bend when axial forces are applied by a surgeon during the procedure. When the guide bends, it can cause metal shavings to develop due to friction with the drill bit. These metal shavings pose a risk of patient injury.
The affected devices are identified by Lot Numbers 22A01, 22C01, and 22F01. They were distributed worldwide, including in the US, Australia, Japan, and the Netherlands. Healthcare providers and patients who have received these devices should contact the manufacturer or consult with their healthcare provider regarding the potential risk.
The recalled product
- Product
- Betta Link LG Reusable ProngED 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: 110045156
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Hazard
- metal-shaving
- 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: 10818674025819 Lot Numbers: 22A01
- 22C01
- 22F01
Distribution
Distributed nationwide across the United States.
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