Events

Recall of COCR DYNAMIC LOCKING SCREW SELF TAPPING

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNTHES (CANADA) LTD..

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
    45089
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-25
  • 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
    Synthes (canada) ltd. is initiating a voluntary recall of all lots of the 3.7mm and 5.0mm dynamic locking screw (dls). the voluntary recall is being initiated following synthes' receipt of customer complaints of 3.7 and 5.0 mm dls breakages at the distal tip of the pin identified after successful healing and during planned implant removal of the whole construct. there have been no reports of permanent impairment associated with the reason for this recall to date. however synthes is aware that significant elongation of surgical time has occurred in planned implant removals which involved a broken dls screw.

Device

COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Model / Serial
    Model Catalog: 09.213.022S (Lot serial: all lots); Model Catalog: 09.223.090S (Lot serial: all lots); Model Catalog: 09.223.085S (Lot serial: all lots); Model Catalog: 09.223.080S (Lot serial: all lots); Model Catalog: 09.223.075S (Lot serial: all lots); Model Catalog: 09.223.070S (Lot serial: all lots); Model Catalog: 09.223.065S (Lot serial: all lots); Model Catalog: 09.223.060S (Lot serial: all lots); Model Catalog: 09.223.058S (Lot serial: all lots); Model Catalog: 09.223.056S (Lot serial: all lots); Model Catalog: 09.223.055S (Lot serial: all lots); Model Catalog: 09.223.054S (Lot serial: all lots); Model Catalog: 09.223.052S (Lot serial: all lots); Model Catalog: 09.223.050S (Lot serial: all lots); Model Catalog: 09.223.048S (Lot serial: all lots); Model Catalog: 09.223.046S (Lot serial: all lots); Model Catalog: 09.223.044S (Lot serial: all lots); Model Catalog: 09.223.042S (Lot serial: all lots); Model Catalog: 09.223.040S (Lot serial: all lots); Model Catalog: 09.223.038S (Lot serial: all lots); Mod
  • Product Description
    COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC