Device product
Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
Z-0322-2021
Product summary
- Event
- Event 86595
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 76 units
- Official record key
device-enforcement:Z-0322-2021
Official wording
Reason: System does not include a drill guide.
Code information: Lots 370855 373847 373848 373849 377629 373850 373846
Distribution pattern: Distributed to one distributor in Michigan.
Derived failure modes
-
Unknown
System does not include a drill guide.