FDA recall Z-0320-2021

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

Product

Streamline MIS Navigation System Taps, Catalog numbers 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

Reason for recall

The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.

Distribution

Product distributed to Surgalign, a distributor located in Michigan.

Key facts

Status: Terminated
Initiation date: 2020-09-11
Report date: 2020-11-11
Termination date: 2024-05-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Marquette, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0320-2021