Events

Recall of Device Recall Large Combination Clamp component of Synthes External Fixation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, 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
    64159
  • Event Risk Class
    Class 2
  • Event Number
    Z-0941-2013
  • Event Initiated Date
    2013-01-11
  • Event Date Posted
    2013-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115818
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    The l1 hex nuts, used to tighten the large combination clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email FieldAction@synthes.com

Device

Device Recall Large Combination Clamp component of Synthes External Fixation System
  • Model / Serial
    Lot Numbers 6602070, 6582333, 6581191, and 6581193
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
  • Product Description
    Large Combination Clamp/Large External Fixation System, Part Number 390.005 || Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA