The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom posted a field safety notice concerning ATLANTIS™ / PREMIER® / VERTEX® 876-460, 6860460 and 6905712 manufactured by Medtronic Limited.
Medtronic is recalling all lots of an Adjustable Drill Stop which may be used for spinal surgery because there is a possibility that the pre-set drill depth established by the adjustable drill stop could inadvertently change during use with powered instrumentation.
No patient injuries have been reported to date. However, using an 876-460, 6860460 or 6905712 Adjustable Drill Stop could cause irreversible neurologic injury if it penetrated through the posterior cortex of the vertebral body. If this occurred, it would necessitate immediate surgical intervention repairing any damage to the surrounding vasculature/neurologic structures; the injuries could include, but are not limited to, vascular penetration, in the cervico-thoracic region and/or spinal cord damage. Complications of this type of injury may lead to irreversible impairment and/or death.
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 product, please contact your supplier for necessary actions.