NovoCut Suture Manager — Class II medical device recall Z-0250-2016
Terminated recall by Ceterix Orthopedics, Inc., reported 2015-11-18, distributed nationwide. The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot
| Recall number | Z-0250-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ceterix Orthopedics, Inc., Menlo Park, CA, United States |
| Recall initiated | 2015-10-13 |
| Classified | 2015-11-09 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,364 units |
| Lot numbers | M150016, M150056, M150078, M150105, M150136, M150182, M150185, M150202, M150207, M150225, M150239 |
| Model numbers | CTX-001 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0250-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.