Z-0320-2021 Class II Terminated

Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) — Marquette, MI

Recall Details

Product Type
Devices
Report Date
November 11, 2020
Initiation Date
September 11, 2020
Termination Date
May 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
143 units

Product Description

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 Pattern

Product distributed to Surgalign, a distributor located in Michigan.

Code Information

Lot numbers 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733