Events

Recall of RADIAL BROACH ASSY

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

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
    94659
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-17
  • 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
    The result of an audit review [conducted during the month of august 2017] of the currently available data of the stryker rhead radial head and uni-elbow system was found to be inconclusive to continue supporting the performance of the device. consequently stryker has decided to remove the product from the global markets.

Device

RADIAL BROACH ASSY
  • Model / Serial
    Model Catalog: 17-0974 (Lot serial: ALL); Model Catalog: 17-0954 (Lot serial: ALL); Model Catalog: 17-0953 (Lot serial: ALL); Model Catalog: 17-0952 (Lot serial: ALL); Model Catalog: RCN-S2 (Lot serial: ALL); Model Catalog: 17-0929 (Lot serial: ALL); Model Catalog: 17-0992 (Lot serial: ALL); Model Catalog: RCN-S4 (Lot serial: ALL); Model Catalog: RCN-S3 (Lot serial: ALL); Model Catalog: 17-0967 (Lot serial: ALL); Model Catalog: RCN-H4 (Lot serial: ALL); Model Catalog: 9230100 (Lot serial: ALL); Model Catalog: RCN-H2 (Lot serial: ALL); Model Catalog: 17-0948 (Lot serial: ALL); Model Catalog: 17-0947 (Lot serial: ALL); Model Catalog: 17-0946 (Lot serial: ALL); Model Catalog: RHA-H4 (Lot serial: ALL); Model Catalog: RHA-H3 (Lot serial: ALL); Model Catalog: RHA-H2 (Lot serial: ALL); Model Catalog: RHA-S4 (Lot serial: ALL); Model Catalog: RHA-S3 (Lot serial: ALL); Model Catalog: RHA-S2 (Lot serial: ALL); Model Catalog: 17-0972 (Lot serial: ALL); Model Catalog: 17-0951 (Lot serial: ALL); Model Catalog: 17-0950 (Lo
  • Product Description
    RADIAL BROACH ASSY;RECON - RADIAL IMPLANT - STANDARD;RESECTION GUIDE RHEAD;RHEAD RECON ASSEMBLY TOOL;RECON - RADIAL IMPLANT - HEAD;RHEAD EXTENDED STEM AWL;STANDARD HEAD TRIAL;RHEAD RADIAL IMPLANT HEAD;RHEAD RADIAL IMPLANT STANDARD STEM;STANDARD STEM TRIAL
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC