Recall Z-0322-2021— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Name: FDA recall Z-0322-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-24

Class II · Ongoing

Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2020-09-24. It names one FDA 510(k) clearance: K200095. Product: Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.. Reason: System does not include a drill guide..

Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Classification: Class II
Status: Ongoing
Initiated: 2020-09-24
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 OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.

Reason for recall

System does not include a drill guide.

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