Events

Recall of Device Recall Synthes Midfoot Fusion Bolt

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
    65955
  • Event Risk Class
    Class 2
  • Event Number
    Z-0014-2014
  • Event Initiated Date
    2013-03-08
  • Event Date Posted
    2013-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121016
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    A post market safety review following several customer complaints indicated additional clarification was necessary in the midfoot fusion bolt technique guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
  • Action
    An "Urgent Notice: Medical Device Recall" letter dated March 8, 2013 was sent to customers asking them to check their inventory, remove all affected product technical guides from use, and return them to Synthes along with the Verification form. Customer questions were directed to (610) 719-5450.

Device

Device Recall Synthes Midfoot Fusion Bolt
  • Model / Serial
    Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
  • Product Description
    Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
  • 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