medical Class II Updated 2020-11-04

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline MIS Navigation System Taps, Catalog Nos. 04-C

Recalled Product

Streamline MIS Navigation System Taps, Catalog Nos. 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 Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.


Hazard / Issue

The Streamline Navigation System taps have experienced binding with other devices.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
View official government recall

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