Z-0299-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 24, 2020
- Termination Date
- September 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 units
Product Description
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.
Reason for Recall
The Streamline Navigation System taps have experienced binding with other devices.
Distribution Pattern
US Nationwide distribution including in the state of Michigan.
Code Information
Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733