Medical device manufacturer, ETHICON, has issued a medical device safety alert concerning its PERMA-HAND Silk Suture (also referred to as MERSILK Silk Suture) [Product Code: W584; Lot number: JCQ247].
The manufacturer has initiated a voluntary medical device removal of one lot of ETHICON PERMA-HAND Silk Suture. Product from the affected lot was found to have an open sterile packaging seal which could compromise device sterility. At this time, the manufacturer has received no reports of Adverse Events for this issue.
According to the manufacturer's Health Hazard Evaluation, there is an extremely rare probability of adverse consequences in patients in whom these sutures were used.
Healthcare practitioners that have treated patients using product from the affected lots should continue to follow those patients in the usual manner.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 January 2017