Events

Recall of Device Recall Synthes Spine Click X Pedicle Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, 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
    64173
  • Event Risk Class
    Class 2
  • Event Number
    Z-0938-2013
  • Event Initiated Date
    2013-01-11
  • Event Date Posted
    2013-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115816
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Reason
    Lot number 7542279, of the 45 mm click 'x pedicle screw (part number 487.072), was incorrectly etched as "click 'x pedicle screw 05.2 l40 tan violet" although the actual length of the screw is 45 mm.
  • Action
    The firm initiated a recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter, dated January 11, 2013, to all consignees. The letter identified the affected product and the issue, as well as requested that consignees examine their inventory for the product(s) with the identified Part and Lot Numbers, remove them from use, and return them to Synthes. Customers were to follow the steps provided in the letter regarding if they had or did not have any of the identified affected product. Questions were to be directed to 610-719-5450 or Fieldaction@synthes.com.

Device

Device Recall Synthes Spine Click X Pedicle Screw
  • Model / Serial
    Lot Number 7542279
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
  • Product Description
    Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. || Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA