Events

Recall of Device Recall Synthes 2.7mm LCP Ulna Osteotomy 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
    67263
  • Event Risk Class
    Class 2
  • Event Number
    Z-1274-2014
  • Event Initiated Date
    2014-01-07
  • Event Date Posted
    2014-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125109
  • 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
    The drill template and the saw guide for the ulna osteotomy system may exhibit jamming, bending, or breaking of the screw connecting the saw guide to the drill template or jamming, bending, or breaking of the k-wire during fixation of the drill template.
  • Action
    A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.

Device

Device Recall Synthes 2.7mm LCP Ulna Osteotomy System
  • Model / Serial
    Part Nos. 03.111.900 through 03.111.905, with Lot Nos. 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
  • Product Description
    Drill Template and the Saw Guide for the Ulna Osteotomy System. || Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
  • 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