Events

Safety Alert Or Field Safety Notices for CALAXO interference screw implants

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Smith & Nephew Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/076
  • Event Number
    CON2032595
  • Date
    2007-10-04
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032595
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Recall due to pre-tibial soft tissue swelling after implantation of calaxo screws leading to the need for surgical intervention to remove any remaining screw fragments.
  • Action
    Identify and quarantine any unimplanted affected devices. Do not implant affected devices. Return affected devices to the manufacturer. Identify and quarantine any unimplanted affected devices. Do not implant affected devices. Return affected devices to the manufacturer. Identify all patients implanted with this screw. If they present with pre-tibial swelling within 2-36 weeks of implantation, consider: aspirating the area for routine cultures local debridement and removal of any remaining screw fragments replacement with an alternative screw or bone graft if necessary. Report all adverse incidents related to CALAXO screws to the implant manufacturer and the MHRA.

Device

CALAXO interference screw implants
  • Model / Serial
  • Product Description
    Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc. All lot numbers and all item codes distributed since 2006. Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate ligament (ACL) reconstruction. Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is currently investigating the cause of this problem. Most cases resolved without intervention. A small number of cases needed local debridement and removal of any remaining screw fragments, or replacement with an alternative screw or bone graft. The manufacturer estimates that about 2,550 devices have been used in the UK since 2006. The manufacturer is aware of seven reported cases of inflammation in the UK of which two required implant revision. The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who were known to use CALAXO about this product recall in August 2007 (see MHRA website). This notice is to facilitate the recall.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc