Events

Recall of STEP DRILL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMPLANT DIRECT SYBRON MANUFACTURING 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
    32385
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Implant direct sybron manufacturing llc is recalling 3 lots of the dgde directguide drill extender (dgde) and 22 lots of associated products that contain dgde as an accessory. through internal regulatory affairs evaluation (hhe) process company found a possible safety issue with the retention of the drill when the dgde is in use. this discrepancy may lead to the possibility of the dgde dropping the drill. the company's current data indicates the possibility of this occurring is unlikely (0.69%).

Device

STEP DRILL
  • Model / Serial
    Model Catalog: SPCST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: IBST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: DGDE (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: BST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: RBST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: ICST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: CST (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: RCST (Lot serial: >10 NUMBERS CONTACT MFG.)
  • Product Description
    DGDE- DIRECTGUIDE DRILL EXTENDER
  • Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC

Manufacturer

IMPLANT DIRECT SYBRON MANUFACTURING LLC