FDA-Device2020-04-01Class II
FlipCutter III Drill
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Hazard
There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
Sold states
Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
Affected count
6625 units
Manufactured in
Kibbutz Gatton, N/A, Naharia, N/A, Israel
Products
FlipCutter III Drill
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2020Don't want to check this manually?
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