Events

Recall of S4 OCCIPITAL CERVICAL SPINAL SYSTEM - OCCIPITAL PLATE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AESCULAP IMPLANT SYSTEMS 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
    19048
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-31
  • 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
    Ifu does not contain instructions how to reassemble the torque wrench after reprocessing.

Device

S4 OCCIPITAL CERVICAL SPINAL SYSTEM - OCCIPITAL PLATE
  • Model / Serial
    Model Catalog: SW205T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW202T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW203T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW204T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW002T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW003T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW216T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW126T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW214T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW213T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW212T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW211T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW210T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW209T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW208T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW207T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW206T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW134T (Lot serial: ALL LOT NUMBERS); Model Catalog: SW133T (Lot serial: ALL LOT NUMBERS); Model Catalog: S
  • Product Description
    S4 OCCIPITAL PLATE
  • Manufacturer
    AESCULAP IMPLANT SYSTEMS LLC

Manufacturer

AESCULAP IMPLANT SYSTEMS LLC