Events

Recall of Device Recall DORO(R) Sterile Disposable Skull Pins

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pro-Med Instruments Gmbh.

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
    78501
  • Event Risk Class
    Class 2
  • Event Number
    Z-0193-2018
  • Event Initiated Date
    2017-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159669
  • 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
    Holder, head, neurosurgical (skull clamp) - Product Code HBL
  • Reason
    The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. the breakage occurred at the very distal end of the conical part of the skull pin tip.
  • Action
    Pro-Med Instruments Gmbh initiated their recall by email on October 30, 2017. The recall notice stated the following: " Actions to be taken by the customer I user: Review this notification and ensure that all users of the affected products are informed of this urgent field safety notice. If you have transferred the affected products to third parties, please forward a copy of this letter or inform the below mentioned contact person. Customers were instructed to check their stock for any affected products If you have any affected products on stock, please quarantine them and send the products back to us. You will receive a replacement as soon as we have received your "Acknowledgement and Receipt Form" and know your current stock. Check any products or records of the affected LOTs used prior to receipt of this field safety notice if the tips have been intact after the surgery. If the tips have not been intact, ensure that any remaining parts are removed from the patient. There are no further specific patient monitoring actions necessary related to this Field Safety Notice. If after reviewing this notification you have any further questions or queries please discuss them with your pro med instruments sales representative Please complete the attachment "Acknowledgement and Receipt Form" and return by Fax or email (see under nr. 8. below) to pro med instruments GmbH to confirm receipt by the 10th of November 2017 at the latest."

Device

Device Recall DORO(R) Sterile Disposable Skull Pins
  • Model / Serial
    Lots: 17041 and 17272
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
  • Product Description
    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY || The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
  • Manufacturer
    Pro-Med Instruments Gmbh

Manufacturer

Pro-Med Instruments Gmbh