Events

Recall of Synthes Sterile Reaming Rods

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    75502
  • Event Risk Class
    Class 2
  • Event Number
    Z-0641-2017
  • Event Initiated Date
    2016-10-03
  • Event Date Posted
    2016-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150553
  • 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
    Reamer - Product Code HTO
  • Reason
    The peel pouches for the affected reaming rods and extraction hooks are delaminating.
  • Action
    DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.

Device

Synthes Sterile Reaming Rods
  • Model / Serial
    Catalog ID 355.042S, Lot Numbers: H085634; H094463.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide
  • Product Description
    2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA