Events

Recall of Device Recall Synthes Titanium Cannulated Humeral Nail

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
    66419
  • Event Risk Class
    Class 2
  • Event Number
    Z-0407-2014
  • Event Initiated Date
    2013-07-30
  • Event Date Posted
    2013-11-27
  • 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=122363
  • 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
    Nail, fixation, bone - Product Code JDS
  • Reason
    The packaging incorrectly depicts the synthes titanium cannulated humeral nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.

Device

Device Recall Synthes Titanium Cannulated Humeral Nail
  • Model / Serial
    Part # Lot #    04.001.620S 7115414  04.001.620S 7115417  04.001.620S 7115509  04.001.620S 7115510  04.001.622S 7115533  04.001.636S 7117902  04.001.636S 7117916  04.001.638S 7117924  04.001.640S 7119089  04.001.640S 7119107  04.001.642S 7117995  04.001.642S 7119125  04.001.644S 7117998  04.001.218S 7327816  04.001.444S 7379241  04.001.620s 7265517
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
  • Product Description
    Synthes Titanium Cannulated Humeral Nail || Intended to aid in the alignment and stabilization of humeral fractures
  • 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