Device product
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Z-0250-2016
Product summary
- Event
- Event 72500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1364 units
- Official record key
device-enforcement:Z-0250-2016
Official wording
Reason: The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Code information: Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.