FDA recall Z-0322-2021

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

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 for recall

System does not include a drill guide.

Distribution

Distributed to one distributor in Michigan.

Key facts

Status: Ongoing
Initiation date: 2020-09-24
Report date: 2020-11-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Marquette, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2021