BETTA LINK SR Knotless Implant Kit Drill Guides May Bend During Surgery
The FDA has recalled BETTA LINK SR Knotless Implant Kits because the drill guides may bend during surgical procedures, potentially releasing metal shavings. This affects surgeons and patients undergoing orthopedic ligament and tendon repair procedures worldwide.
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 recall of a surgical implant kit with a structural defect in the drill guides. Although the hazard is potential with no reported injuries, this risk-of-harm product warrants a High rating given the surgical context and potential for patient injury.
Plain-English summary
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. is recalling the BETTA LINK SR KNOTLESS IMPLANT KIT, used in orthopedic surgeries to repair ligament and tendon damage. Affected lot numbers span 2021 and 2022.
The drill guides in the kit may bend when surgeons apply axial forces during the procedure. This bending results in metal shavings from friction with the drill bit, creating a potential injury risk to patients during or after surgery. No injuries have been reported.
The device has been distributed worldwide to the United States, Australia, Japan, and the Netherlands. It is used during soft tissue to bone fixation procedures in ligament and tendon repair surgeries.
The recalled product
- Product
- BETTA LINK SR 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:110045154
- 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 (20)
- UDI-DI: 0818674025765 Lot Numbers: 21R01
- 21R02
- 21R03
- 22C02
- 22C03
- 22C06
- 22C08
- 22E01
- 22E02
- 22F01
- 22F02
- 22F03
- 22J01
- 22J02
- 22J03
- 22K01
- 22K02
- 22K03
- 22K04
- 22K05
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
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