Events

Recall of Device Recall Synthes

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
    67499
  • Event Risk Class
    Class 2
  • Event Number
    Z-1456-2014
  • Event Initiated Date
    2014-01-30
  • Event Date Posted
    2014-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125578
  • 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
    Screwdriver, skullplate - Product Code GXL
  • Reason
    The cmf battery powered driver graphic case contains outlines of the battery powered driver, taps, screwdriver blades, and a screw holding sleeve. however, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
  • Action
    Synthes sent an Urgent Notice: Field Safety Notification letter dated January 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions; Please see the Battery Powered Driver Users Manual for on-label procedures. You can access an electronic version of the Battery Powered Driver Users Manual by accessing the following : linlc http://www.synthes.com/pages/default.aspx. Click on North America Tab at the top of the screen, and then type Battery Powered Driver Users Manual in the search bar to download the Users Manual Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the graphic case has been forwarded to another facility, contact that facility. " Maintain a copy of this notice. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.

Device

Device Recall Synthes
  • Model / Serial
    Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974,  6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225,  6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870,  6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395,  7138319.
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
  • 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