BETTA LINK LG Implant Drill Guide Bending Risk
T.A.G. MEDICAL PRODUCTS is recalling BETTA LINK LG KNOTLESS IMPLANT KIT because drill guides may bend during surgical use, potentially 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: FDA Class II medical device recall with no reported illnesses or injuries to date. The hazard is real (drill guides bending and creating metal shavings during surgery) but injury remains theoretical. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring as High (3).
Plain-English summary
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. is recalling the BETTA LINK LG KNOTLESS IMPLANT KIT (Part Number 110045160), a surgical implant used in soft tissue to bone fixation for ligament and tendon repair or reconstruction.
The recall was issued because the drill guides in the kit may bend when surgeons apply axial forces during the procedure. This bending can cause friction with the drill bit, resulting in metal shavings that could injure patients.
The product has been distributed worldwide in the United States, Australia, Japan, and the Netherlands. Affected units are identified by 31 specific lot numbers ranging from lot 21E28 through lot 22P16.
Healthcare facilities and surgeons should stop using affected units immediately and contact T.A.G. MEDICAL PRODUCTS CORPORATION for instructions on returns or replacement. Patients who have received this implant should consult with their healthcare provider about their treatment.
The recalled product
- Product
- BETTA LINK LG KNOTLESS IMPLANT KIT-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: 110045160
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Hazard
- drill-guide-bending
- metal-shavings
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 (20)
- UDI-DI: 10818674025772 Lot Numbers: 21E28
- 21R15
- 21R16
- 21R32
- 21R35
- 22C19
- 22E29
- 22F10
- 22F35
- 22J07
- 22J08
- 22J09
- 22J18
- 22J19
- 22J27
- 22J28
- 22J33
- 22K23
- 22K24
- 22K32
Distribution
Distributed nationwide across the United States.
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