FDA recall Z-0299-2021

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · Class II · device

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.

Reason for recall

The Streamline Navigation System taps have experienced binding with other devices.

Distribution

US Nationwide distribution including in the state of Michigan.

Key facts

Status
Terminated
Initiation date
2020-09-24
Report date
2020-11-04
Termination date
2024-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marquette, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0299-2021