Device 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.
Z-0299-2021
Product summary
- Event
- Event 86559
- Status
- Terminated
- Classification
- Class II
- Quantity
- 420 units
- Official record key
device-enforcement:Z-0299-2021
Official wording
Reason: The Streamline Navigation System taps have experienced binding with other devices.
Code information: Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
Distribution pattern: US Nationwide distribution including in the state of Michigan.
Derived failure modes
-
Unknown
The Streamline Navigation System taps have experienced binding with other devices.