Events

Recall of Device Recall Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short

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
    74416
  • Event Risk Class
    Class 2
  • Event Number
    Z-2199-2016
  • Event Initiated Date
    2016-05-31
  • Event Date Posted
    2016-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147484
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    Depuy synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with mr safety information not meeting the current astm standard.
  • Action
    DePuy Synthes mailed an URGENT MEDICAL DEVICE FIELD SAFETY NOTIFICATION letter to their customers (Hospital Personnel, including Imaging Department Personnel and DePuy Synthes Colleague) to inform them of the recall and actions to take. The letter identified the affected, problem and actions to be taken. The letter instructed customers not to use the affected Instruments which are labeled or etched MR Safe and MR Conditional during MRI scans. Customers were asked to review the information contained in the Field Safety Notification letter and complete the Verification Section located on page 3 of this notification. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Device Recall Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short
  • Model / Serial
    Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.
  • Product Description
    Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 || Product Usage: || The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
  • 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