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
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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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