Events

Recall of Device Recall Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN

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
    66421
  • Event Risk Class
    Class 2
  • Event Number
    Z-0387-2014
  • Event Initiated Date
    2013-07-31
  • Event Date Posted
    2013-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122365
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    The large buttress compression nut for blade guide sleeve tfn was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: Our records indicate you received this product. Synthesis requesting that the product be returned: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form {page 3 of this letter) with the product to: "Credit/Returns, Synthes, .1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. "Return the documents to Synthes by. " Fax: 1-888-731-7952 or " Scan/email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue

Device

Device Recall Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN
  • Model / Serial
    Part # Lot #    SD357.371 5734551   6083065   6538811   6631975   6703191   6703190   6841538
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.
  • Product Description
    Large Buttress Compression Nut For Blade Guide Sleeve TFN || The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
  • 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