Z-0250-2016Class II

NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in...

Name: Z-0250-2016 NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in...
Creator: Ceterix Orthopedics, Inc.
Published: 2015-10-13
License: https://open.fda.gov/license/

Ceterix Orthopedics, Inc. / initiated 2015-10-13 / Terminated / root cause: design

FDA source

Ceterix Orthopedics, Inc. began a recall of NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery on 2015-10-13. FDA classified it as Class II and gives the reason as "The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0250-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-13
Posted: 2015-11-09
Terminated: 2016-02-12
Recalling firm: Ceterix Orthopedics, Inc.
Product: NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Product code: NBH Accessories, Arthroscopic
Reason for recall: The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Root cause tag: design
FDA root cause: Device Design
Action: Ceterix Orthopaedics sent an Urgent Field Safety notification letter dated October 13, 2015, to all affected sites. The product was identified, reason for recall explained and letter contains list of product lot numbers affected. Customers were instructed to identify and quarantine the affected product, contact Ceterix Orthopaedics to arrange a no cost return, and complete and return the attached acknowledgement form. Customers with questions were instructed to call 1-888-305-0615 or email: [email protected]. For questions regarding this recall call 650-396-3478.
Quantity in commerce: 1364 units
Distribution: Nationwide Distribution
Product codes and lots: Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0250-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0250-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

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)