Events

Recall of Device Recall DePuy Synthes Titanium Recon Screws

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
    71361
  • Event Risk Class
    Class 2
  • Event Number
    Z-1915-2015
  • Event Initiated Date
    2015-05-27
  • Event Date Posted
    2015-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137450
  • 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
    Certain lots of the titanium recon screws (6.5mm ) were found to contain the incorrect insert gp0760-a (synthes titanium buttress locking plate system), instead of the correct insert gp0706-e (synthes titanium intramedullary nails and components).
  • Action
    DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: ¿ Review the information listed in this notification. ¿ Forward this notice to anyone in your facility that needs to be informed. ¿ Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by: ¿ Fax: (888) 912-2182 or ¿ Scan/email: Synthes4844@stericycle.com ¿ If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. ¿ Maintain a copy of this notice. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.

Device

Device Recall DePuy Synthes Titanium Recon Screws
  • Model / Serial
    Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
  • 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