Events

Recall of Device Recall 7.5mm Ti Solid Humeral Nail 230 mm Sterile

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
    55147
  • Event Risk Class
    Class 2
  • Event Number
    Z-1548-2010
  • Event Initiated Date
    2010-02-25
  • Event Date Posted
    2010-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90076
  • 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
    Potential compatibility issue.
  • Action
    The recalling firm, Synthes, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated February 25, 2010, return receipt requested, to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately cease use of the products, examine their inventory for the part/lot combinations and remove the recalled devices from their shelves, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number and return the recalled product with the letter; however, if the customers do not have the identified product , they should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at lewis.lynne@synthes.com. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.

Device

Device Recall 7.5mm Ti Solid Humeral Nail 230 mm Sterile
  • Model / Serial
    Catalog/Part number 462.723S. Lot number 6303874 exp 12/2018
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: LA, MA, ME, NC, PA and VA.
  • Product Description
    7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S || Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological 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