Medical device manufacturer, Synthes, has issued a field safety notice concerning AnspachR Single-use Cutting Burs and Irrigation Clips used with AnspachR electri and pneumatic High Speed Drill System.
This removal is being conducted because AnspachR has observed separation between the clear layers of the pouch during real time aging studies. As a result of the separation, it is possible to have a breach in the sterile barrier.
This removal action is limited to product that is packaged in a Tyvek pouch where the product is retained within a Tube. Products that are retained within a Snap Tray are NOT affected by this removal action.
AnspachR has not received any reports of incidents or adverse events related to this issue. According to the local supplier, affected products have been distributed in HK.
If you are in possession of the affected products, please contact your supplier for necessary actions.