FDA-Device2020-11-11Class II
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN
Hazard
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Sold states
Product distributed to Surgalign, a distributor located in Michigan.
Affected count
143 units
Manufactured in
375 River Park Cir, N/A, Marquette, MI, United States
Products
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0320-2021Don't want to check this manually?
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