Events

Recall of Device Recall The Synthes Hohmann Retractor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, 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
    67560
  • Event Risk Class
    Class 2
  • Event Number
    Z-1457-2014
  • Event Initiated Date
    2014-02-11
  • Event Date Posted
    2014-04-15
  • 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=125719
  • 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
    Retractor - Product Code GAD
  • Reason
    The synthes hohmann retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450.

Device

Device Recall The Synthes Hohmann Retractor
  • Model / Serial
    part no. 399.24, lot number T974302
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
  • Product Description
    The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm || Product Usage: Used to expose bone for procedures.
  • Manufacturer
    Synthes, Inc.

Manufacturer

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