Recall Z-2945-2018 ยท NBH Accessories, Arthroscopic
Ceterix Orthopedics, Inc.
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
| Date | May 16, 2018 |
| Status | Terminated |
| Reason | Possible nonconforming blades may result in a higher than specified cut force required to cut the suture. |
| Root cause | Nonconforming Material/Component |
| Action | Ceterix Orthopaedics notified customers via an "Urgent Field Safety Notice: for NovoCut Suture Manager. The letter dated May 16, 2018 provided the following: Details on affected devices, Description of the problem, Risks to Health, Actions to be taken by the customer, and Contact reference person. |
| Quantity | 96 units |
| Distribution | United States distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.