Device product
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
Z-0320-2021
Product summary
- Event
- Event 86591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 143 units
- Official record key
device-enforcement:Z-0320-2021
Official wording
Reason: The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Code information: Lot numbers 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
Distribution pattern: Product distributed to Surgalign, a distributor located in Michigan.
Derived failure modes
-
Unknown
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.