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RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNT
Recalled November 4, 2020 · FDA recall Z-0299-2021 · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Hazard
The Streamline Navigation System taps have experienced binding with other devices. · FDA Class II
Units
420 units
Sold at
US Nationwide distribution including in the state of Michigan.
Description
The Streamline Navigation System taps have experienced binding with other devices.
Product
Streamline MIS Navigation System Taps, Catalog Nos. 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 Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Manufacturer(s)
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →