Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning Repliform Tissue Regeneration Matrix [Material Number (UPN): M0068202410; Lot: AH102318010, AH102317009, AH102318026; Expiration Date: 31 January 2017].
Boston Scientific, as the distributor of LifeCell Corporation's Repliform Tissue Regeneration Matrix, is implementing a recall on behalf of LifeCell Corporation. LifeCell has informed Boston Scientific Corporation that the incorrect ink was used in the manufacture of the printed backing component of the lots identified below. This could potentially lead to the transfer of ink from the printed backing component to the Repliform Tissue Regeneration Matrix and subsequent patient implantation.
Per LifeCell's toxicological analysis and health assessment, exposure to the chemicals found in the ink at the levels used is unlikely to pose a safety concern. If affected Repliform Matrix was implanted, there is a potential for a local transient inflammatory response. There are no identified long term health consequences.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 May 2015