The Recall Desk

FDA (Devices) recall action 92410

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. recalled 6 products on 2023-07-12

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2023-07-12
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • HighFDA (Devices)··2023-07-12

    BETTA LINK LG Implant Drill Guide Bending Risk

    T.A.G. MEDICAL PRODUCTS is recalling BETTA LINK LG KNOTLESS IMPLANT KIT because drill guides may bend during surgical use, potentially creating metal shavings that could injure patients.

    Product
    BETTA LINK LG 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: 110045160
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-07-12

    Surgical drill guides may bend and produce metal shavings during use

    T.A.G. MEDICAL PRODUCTS CORPORATION is recalling Betta Link LG Reusable ProngED Guides used in orthopedic surgery because the guides may bend when force is applied, creating metal shavings that could injure patients.

    Product
    Betta Link LG 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: 110045156
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-07-12

    Betta Link LG Surgical Guide May Deform and Produce Metal Shavings

    Betta Link LG surgical guides used in soft tissue and bone repair may bend under pressure during surgery, potentially releasing metal shavings that could injure patients. The manufacturer is recalling affected units in the U.S. and internationally.

    Product
    Betta Link LG Reusable Fishmouth 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: 110045157
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-07-12

    BETTA LINK SR Reusable Fishmouth Guide may bend and shed metal shavings

    T.A.G. Medical Products is recalling BETTA LINK SR Reusable Fishmouth Guides (Part Number 110045151) because the drill guides may bend during surgical use and result in metal shavings. The risk to patients includes potential injury.

    Product
    BETTA LINK SR REUSABLE FISHMOUTH 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: 110045151
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-07-12

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-07-12

    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.

    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
    Category
    Distribution
    0 states