FDAFDA · Food and drugs·Recall number Z-2062-2023
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
Published July 12, 2023 · Recall initiated: May 4, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
- Lot
- UDI-DI:10818674025802 Lot Numbers: 22A01, 22C01, 22C02, 22F01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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