Medical device manufacturer, DePuy Synthes, has issued a field safety notice concerning the "Handle, flexible [No.: 355.220]". All lot numbers of the old handle (355.280) are affected.
The manufacturer is initiating a voluntary recall of all lots of the "Handle, flexible, for No. 355.220" (355.280) which is part of the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI), due to the potential lack of the ability to thoroughly clean the instrument.
It was reported by the evaluation department in Monument/USA that while checking the instrument set a discharge from the Handle, flexible was noted. Additionally, an investigation was unable to validate the ability to adequately clean the instrument.
There have been no complaints or adverse events with regards to the issue.
The manufacturer advises users to remove the affected product from use and return them to Synthes. The handles in the field will be replaced with a newly design handle.
According to the local supplier, the affected devices were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 April 2013