CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
NovoCut Suture Manager recalled by Ceterix Orthopedics
Ceterix Orthopedics is recalling NovoCut Suture Manager, distributed nationwide in the US. The recall was initiated on 13 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0250-2016
- FDA event ID
- 72500
- Recalling firm
- Ceterix Orthopedics, Menlo Park, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2015
- FDA classified
- 9 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 13 Oct 2015 | Recall initiated by company | |
| 9 Nov 2015 | Classified by FDA | +27 days |
| 18 Nov 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is NovoCut Suture Manager recalled?
Yes. Ceterix Orthopedics recalled NovoCut Suture Manager on 13 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0250-2016.
Why was it recalled?
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Which lots are affected?
Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ceterix Orthopedics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ceterix Disposable Knot Pusher / Suture Cutter recalled | Ceterix Orthopedics | Other | CA |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |