Events

Recall of Device Recall Synthes Guide Blocks for the Volar Distal Radius Plate System

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
    68442
  • Event Risk Class
    Class 2
  • Event Number
    Z-2087-2014
  • Event Initiated Date
    2014-05-29
  • Event Date Posted
    2014-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127713
  • 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
    orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The guide blocks for the 2 column plate 6 hole head (volar distal radius plate system) were found to be labeled incorrectly. part no. 03.111.600 (right) was found in the package labeled part no. 03.111.601 (left). the laser etching denoting the orientation on the part is correct.
  • Action
    An urgent field correction notification, dated May 29, 2014, was sent to end users and sales consultants which described the product, problem, and actions to be taken.

Device

Device Recall Synthes Guide Blocks for the Volar Distal Radius Plate System
  • Model / Serial
    part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide and Bermuda.
  • Product Description
    Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
  • 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