FDA Device recall Z-0250-2016
NovoCut Suture Manager
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of NovoCut Suture Manager by Ceterix Orthopedics, citing the NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0250-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-13 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ceterix Orthopedics |
| Distribution | US |
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.
Identifiers
| code_info | Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0250-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.