Events

Recall of REFLECTION 3 ACETABULAR SYSTEM - INTL CERAMIC ACETABULAR LINER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW INC..

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
    137863
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-15
  • 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
    During the manufacturing phase for certain batches of the r3 ceramic acetabular liners the titanium rings were pressed onto the ceramic component with a higher force than allowed by the manufacturing specifications. this has the potential to result in lower than expected strength for the liners.

Device

REFLECTION 3 ACETABULAR SYSTEM - INTL CERAMIC ACETABULAR LINER
  • Model / Serial
    Model Catalog: 71331652 (Lot serial: 10FT43611); Model Catalog: 71331648 (Lot serial: 10FT43611); Model Catalog: 71331648 (Lot serial: 10FT43676); Model Catalog: 71331648 (Lot serial: 09JT35943); Model Catalog: 71331652 (Lot serial: 10FT43676); Model Catalog: 71331652 (Lot serial: 09JT35943)
  • Product Description
    REFLECTION 3 ACETABULAR SYSTEM - INTL CERAMIC ACETABULAR LINERS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.