T.A.G. Medical recalls Betta Link SR Knotless Implant Kit (lot numbers 21R01-22P05) due to drill guides bending during surgery, risking metal shavings and patient injury.
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.
T.A.G. Medical is recalling Betta Link SR Knotless Implant Kits that may bend during surgery, potentially causing metal shavings that could injure patients. This recall affects specific lot numbers produced between 2021 and 2022.
During surgical procedures, the drill guides in these kits may bend when axial forces are applied by the surgeon. This bending can cause metal shavings to form due to friction with the drill bit, which could lead to patient injury.
Surgical patients and medical professionals using the Betta Link SR Knotless Implant Kit for soft tissue to bone fixation procedures. Those with the specific lot numbers listed in the recall are most at risk.
Check the lot numbers on the kit packaging: 21R01 through 22P05. These kits are intended for soft tissue to bone fixation in ligament or tendon repairs and reconstruction surgeries.
Look for lot numbers on the packaging: 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.
The drill guides may bend during surgery, causing metal shavings that could injure patients.
Check the lot numbers on the packaging: 21R01 through 22P05.
No, but you should check the lot numbers to see if your kit is affected. If it is, contact T.A.G. Medical for further instructions.
We’ve drafted a message you can send T.A.G. Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2060-2023 — T.A.G. Medical T.A.G. Medical Hello, I own a T.A.G. Medical that is covered by recall Z-2060-2023 from T.A.G. Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.