Events

Recall of POLARUS CAP SCREW ASSEMBLY

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

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
    74845
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-01
  • 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
    It has come to acumed's attention that some of its products have been distributed in canada without a valid medical device licence issued by health canada. acumed is recalling these products from canada only.

Device

POLARUS CAP SCREW ASSEMBLY
  • Model / Serial
    Model Catalog: HR-0001-S (Lot serial: NA); Model Catalog: PL-PHXGL (Lot serial: NA); Model Catalog: PL-PHXGR (Lot serial: NA); Model Catalog: PL-2127 (Lot serial: NA); Model Catalog: PL-MCPL (Lot serial: NA); Model Catalog: ATF-200-S (Lot serial: NA); Model Catalog: ATF-180-S (Lot serial: NA); Model Catalog: ATF-160-S (Lot serial: NA); Model Catalog: ATF-140-S (Lot serial: NA); Model Catalog: 70-0096-S (Lot serial: NA); Model Catalog: 70-0095-S (Lot serial: NA); Model Catalog: 30-0033-S (Lot serial: NA); Model Catalog: ATF-220-S (Lot serial: NA); Model Catalog: PL-MCPR (Lot serial: NA); Model Catalog: PL-SR27 (Lot serial: NA); Model Catalog: PL-SR39 (Lot serial: NA); Model Catalog: PL-SR40 (Lot serial: NA); Model Catalog: PL-SR41 (Lot serial: NA)
  • Product Description
    POLARUS CAP SCREW ASSEMBLY;PROXIMAL HUMERAL PLATE EXTRA LONG;CONGRUENT BONE PLATE SYSTEM - DRILL GUIDE;1ST MCP FUSION PLATE;ACUTRAK FUSION DEVICE;LOCKING CLAVICLE PLATE 8 HOLE STRAIGHT;CONGRUENT BONE PLATE SYSTEM - REAMER
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC