BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in recall: Foreign Material
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…
Why was BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in recalled?
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 22K07, 22K08, 22K09, 22K10, 22K11, 22M01, 22M02, 22M03, 22M04, 22N01, 22P01, 22P02, 22P03, 22P04, 22P05, 22R01
- 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…
- Recalling firm
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Quantity
- N/A
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)