Medical device manufacturer, Synthes, has initiated a field safety corrective action concerning Holding Clamps for Multi Vector Distractor. The affected part numbers included 487.938, 487.939, 487.940, 487.941 and 487.942.
The manufacturer has received two complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. No patient harm was reported. The manufacturer advises the affected users to quarantine the affected products.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 9 April 2013