It has come to our attention that medical device manufacturer, Pioneer Surgical Technologies, has issued a field safety corrective action concerning Nubac Trial Inserter – 43-TRL-INSERTER.
The manufacturer has identified that the affected device can wear causing it not to function as designed. This wear may cause the trial spacer to become detached from the inserter while in use. If this takes place, the trial spacer may be difficult to remove from the patient which may cause patient injury during this removal process.
The manufacturer advised that the device should be inspected prior to every use and they have developed a test fixture to be used to assist in the determination of the wear of the device.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted 03 May 2012