Recall Z-2945-2018— Ceterix Orthopedics, Inc.
Class II · Terminated
Class II FDA medical device recall by Ceterix Orthopedics, Inc., initiated 2018-05-16, terminated 2020-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.. Reason: Possible nonconforming blades may result in a higher than specified cut force required to cut the suture..
- Recalling firm
- Ceterix Orthopedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-16
- Terminated
- 2020-08-24
- Firm location
- Fremont, CA, United States
Product description
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Reason for recall
Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.
Data sourced from openFDA. This site is unofficial and independent of the FDA.