Recall Z-0299-2021— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Name: FDA recall Z-0299-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-24

Class II · Terminated

Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2020-09-24, terminated 2024-09-16. It names one FDA 510(k) clearance: K200095. 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: The Streamline Navigation System taps have experienced binding with other devices..

Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Classification: Class II
Status: Terminated
Initiated: 2020-09-24
Terminated: 2024-09-16
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K200095 — Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.·cleared 2020-06-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.