RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-F

Recalled November 11, 2020 · FDA recall Z-0322-2021 · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Hazard

System does not include a drill guide. · FDA Class II

Units

76 units

Sold at

Distributed to one distributor in Michigan.

Description

System does not include a drill guide.

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.

Manufacturer(s)

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →