Z-2945-2018Class II

Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic...

Name: Z-2945-2018 Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic...
Creator: Ceterix Orthopedics, Inc.
Published: 2018-05-16
License: https://open.fda.gov/license/

Ceterix Orthopedics, Inc. / initiated 2018-05-16 / Terminated / root cause: manufacturing process

FDA source

Ceterix Orthopedics, Inc. began a recall of Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory on 2018-05-16. FDA classified it as Class II and gives the reason as "Possible nonconforming blades may result in a higher than specified cut force required to cut the suture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2945-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Posted: 2018-08-28
Terminated: 2020-08-24
Recalling firm: Ceterix Orthopedics, Inc.
Product: Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Product code: NBH Accessories, Arthroscopic
Reason for recall: Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ceterix Orthopaedics notified customers via an "Urgent Field Safety Notice: for NovoCut Suture Manager. The letter dated May 16, 2018 provided the following: Details on affected devices, Description of the problem, Risks to Health, Actions to be taken by the customer, and Contact reference person.
Quantity in commerce: 96 units
Distribution: United States distribution.
Product codes and lots: Lot#M180018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2945-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2945-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-28

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)