Device product
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Z-2945-2018
Product summary
- Event
- Event 80688
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 units
- Official record key
device-enforcement:Z-2945-2018
Official wording
Reason: Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.
Code information: Lot#M180018
Distribution pattern: United States distribution.
Derived failure modes
-
Unknown
Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.