Surgical drill guide may bend and produce metal shavings during use
T.A.G. Medical is recalling BETTA LINK SR surgical drill guides due to risk of bending and metal shavings during surgery.
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. The device may bend and produce metal shavings, posing potential injury risk. This is a high-risk product scenario where the hazard is theoretical rather than confirmed.
Plain-English summary
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. is recalling BETTA LINK SR REUSABLE PRONGED GUIDE devices (Part Number 110045150) used in orthopedic and reconstructive surgery. These devices are intended for soft tissue to bone fixation in the repair of ligament or tendon injuries and for reconstruction surgeries. During surgical use, the devices may bend when surgeons apply axial forces, potentially resulting in metal shavings from friction with the drill bit.
The recalled devices include the following lot numbers: 22A01, 22C01, 22C02, and 22F01. The devices have been distributed worldwide, including throughout the United States and in Australia, Japan, and the Netherlands. This recall affects surgeons, surgical facilities, and patients undergoing these procedures.
Healthcare facilities should review the recall notice and contact T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. for guidance on proper device handling or replacement. Patients who have undergone surgery with these devices should consult their healthcare provider with any concerns.
The recalled product
- Product
- BETTA LINK SR 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: 110045150
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Hazard
- metal-shavings
- equipment-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 (4)
- UDI-DI:10818674025802 Lot Numbers: 22A01
- 22C01
- 22C02
- 22F01
Distribution
Distributed nationwide across the United States.
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