Events

Recall of Device Recall LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong

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

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
    37010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0489-2007
  • Event Initiated Date
    2006-12-05
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49756
  • 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
    bone fixation plate - Product Code HRS
  • Reason
    Hole is malformed, leading to reduced construct strength.
  • Action
    All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.

Device

Device Recall LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong
  • Model / Serial
    Catalog number 242.465, Lot number 5373486
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.
  • Product Description
    LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
  • Manufacturer
    Synthes

Manufacturer

Synthes
  • Manufacturer Address
    Synthes, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Source
    USFDA