FDA-Device2023-07-12Class II
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
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
Affected count
N/A
Manufactured in
Kibbutz Gatton, N/A, GAATON, N/A, Israel
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2062-2023Don't want to check this manually?
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