Z-2062-2023 Class II Ongoing
FDA device recall Z-2062-2023 was initiated by T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. on May 4, 2023 and is designated Class II. 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 injur… The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Code Information
UDI-DI:10818674025802 Lot Numbers: 22A01, 22C01, 22C02, 22F01