RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-…

Recall date

September 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0320-2021

FDA classification

Class II

Brand / firm

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

Sold / distributed

Product distributed to Surgalign, a distributor located in Michigan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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