Device 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
Z-2062-2023
Product summary
- Event
- Event 92410
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2062-2023
Official wording
Reason: 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.
Code information: UDI-DI:10818674025802 Lot Numbers: 22A01, 22C01, 22C02, 22F01
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Derived failure modes
-
Foreign material or chemical contamination
metal shavings