Events

Recall of Device Recall Synthes Radial Head Prosthesis System

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
    76182
  • Event Risk Class
    Class 2
  • Event Number
    Z-1124-2017
  • Event Initiated Date
    2016-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152471
  • 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
    Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
  • Reason
    There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
  • Action
    An Urgent Notice was mailed to consignees explaining the reason for the recall. Customers were asked to immediately review their inventories for the affected product and complete and return the Verification form that was included with the notification and return any of the affected product that was found.

Device

Device Recall Synthes Radial Head Prosthesis System
  • Model / Serial
    Part Numbers: 03.402.006 03.402.007 03.402.008 03.402.009 03.402.010 03.402.018 03.402.020 03.402.022 03.402.024 03.402.026 03.402.028 03.402.106 03.402.107 03.402.108 03.402.109 03.402.110 03.402.218 03.402.220 03.402.222 03.402.224 03.402.226 03.402.228 03.402.418 03.402.420 03.402.422 03.402.424 03.402.426 03.402.428 03.402.618 03.402.620 03.402.622 03.402.624 03.402.626 03.402.628 03.402.701 03.402.710 03.402.711 03.402.712 03.402.716 03.402.717 03.402.718 03.402.719 03.402.720 03.402.721 03.402.722 03.402.723 03.402.724 03.402.725 03.402.726 03.402.727 03.402.728 03.402.729 03.402.730 03.402.731 03.402.732 03.402.733 03.402.734 03.402.735 03.402.740 03.402.741 03.402.744 04.402.006S 04.402.007S 04.402.008S 04.402.009S 04.402.010S 04.402.026S 04.402.027S 04.402.028S 04.402.029S 04.402.030S 09.402.018S 09.402.020S 09.402.022S 09.402.024S 09.402.026S 09.402.028S 09.402.218S 09.402.220S 09.402.222S 09.402.224S 09.402.226S 09.402.228S 09.402.418S 09.402.420S 09.402.422S 09.402.424S 09.402.426S 09.402.428S 09.402.618S 09.402.620S 09.402.622S 09.402.624S 09.402.626S 09.402.628S 60.402.001 60.402.002 61.402.001 01.402.001E
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States Nationwide Distribution.
  • Product Description
    Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories || Product Usage: || Intended for primary and revision joint replacement of the radial head.
  • 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