Events

Recall of 5.0 mm Periprosthetic Locking Screw Selftapping 12 mm Sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    73770
  • Event Risk Class
    Class 2
  • Event Number
    Z-1574-2016
  • Event Initiated Date
    2016-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144953
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    This lot of the 5.0 mm periprosthetic locking screw, self-tapping, 12mm sterile, was shipped after the expiration date of may 31, 2012. the label on the product has the correct expiration date.
  • Action
    DePuy Synthes mailed to customers an Urgent Notice informing them they were voluntarily recalling 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm-Sterile, part # 02.221.462S, Lot # 5539094, expiration date May 31, 2012, due to the units being shipped after the expiration date of May 31, 2012. Customers were instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section on page 3 by checking the appropriate box and return the form and product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.

Device

5.0 mm Periprosthetic Locking Screw Selftapping 12 mm Sterile
  • Model / Serial
    Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in IL and IN.
  • Product Description
    5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; || Catalog ID # 02.221.462S || Indicated for fixation of various long bones.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA