Events

Recall of Device Recall Synthes 2.4 mm LCDCP Plate 6 Holes/51mm

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
    66413
  • Event Risk Class
    Class 2
  • Event Number
    Z-0406-2014
  • Event Initiated Date
    2013-07-30
  • Event Date Posted
    2013-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122357
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    A complaint was reported regarding a screw being found in a package labeled for 2.4 mm lc-dcp plate.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.

Device

Device Recall Synthes 2.4 mm LCDCP Plate 6 Holes/51mm
  • Model / Serial
    Part No. 249.926, lot No. 8093100
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.
  • Product Description
    Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm || Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
  • 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