Device product
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Z-1026-2022
Product summary
- Firm
- restor3d Inc.
- Event
- Event 89983
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-1026-2022
Official wording
Reason: Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Code information: Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
Distribution pattern: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Derived failure modes
-
Unknown
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.