Recall Z-0250-2016— Ceterix Orthopedics, Inc.
Class II · Terminated
Class II FDA medical device recall by Ceterix Orthopedics, Inc., initiated 2015-10-13, terminated 2016-02-12. FDA's recall record names no specific 510(k) clearance for this event. Product: NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.. Reason: The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel..
- Recalling firm
- Ceterix Orthopedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-13
- Terminated
- 2016-02-12
- Firm location
- Menlo Park, CA, United States
Product description
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Reason for recall
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Data sourced from openFDA. This site is unofficial and independent of the FDA.