Events

Recall of Suture cutter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ceterix Orthopedics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72500
  • Event Risk Class
    Class 2
  • Event Number
    Z-0250-2016
  • Event Initiated Date
    2015-10-13
  • Event Date Posted
    2015-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141289
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories,arthroscopic - Product Code NBH
  • Reason
    The novocut suture manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
  • 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: docs@ceterix.com. For questions regarding this recall call 650-396-3478.

Device

Suture cutter
  • Model / Serial
    Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    NovoCut Suture Manager; Ceterix catalog number CTX-001. || General and Plastic Surgery: Intended for use in arthroscopic surgery.
  • Manufacturer
    Ceterix Orthopedics, Inc.

Manufacturer

Ceterix Orthopedics, Inc.
  • Manufacturer Address
    Ceterix Orthopedics, Inc., 959 Hamilton Ave, Menlo Park CA 94025-1431
  • Manufacturer Parent Company (2017)
    Ceterix Orthopaedics Inc.
  • Source
    USFDA