Events

Recall of Device Recall Synthes 3.7mm and 5.0mm Dynamic Locking Screw (DLS)

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
    66666
  • Event Risk Class
    Class 2
  • Event Number
    Z-0390-2014
  • Event Initiated Date
    2013-07-22
  • Event Date Posted
    2013-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122920
  • 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
    All lots of 3.7mm and 5.0mm dynamic locking screw (dls) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.

Device

Device Recall Synthes 3.7mm and 5.0mm Dynamic Locking Screw (DLS)
  • Model / Serial
    All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada.
  • Product Description
    3.7mm and 5.0mm Dynamic Locking Screw (DLS) || Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
  • 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