Device product
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Z-0086-2022
Product summary
- Event
- Event 88684
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-0086-2022
Official wording
Reason: Engraving on implants may not match what is listed on the pouch labels.
Code information: Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
Distribution pattern: Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Derived failure modes
-
Unknown
Engraving on implants may not match what is listed on the pouch labels.