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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2060-2023

Related Recalls

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.

May 4, 2023 Other Medical Devices Nationwide View Details →

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.

May 4, 2023 Other Medical Devices Nationwide View Details →

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.

May 4, 2023 Implants & Prosthetics Nationwide View Details →