The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning the recall of the Screw Module ("Screw Caddy") used with the ATLANTIS Anterior Cervical Plate System and the Premier Anterior Cervical Plate System, (Part numbers176-504, 176-503, and 1860503), manufactured by Medtronic Limited.
Medtronic has discovered that the measurement gauge located on the lower corner of the caddy may be out of specification, which could cause a screw to be measured improperly. An incorrect gauge could measure a screw to be approximately 1mm shorter than its actual length.
No patient injuries have been reported to date. However, using an inappropriately long screw could cause irreversible neurologic injury if it penetrated the vertebral body.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 4 September 2012