DuPont Corporation, the manufacturer of the Tyvek material sold to our suppliers (Mangar, Bemis) has introduced a change in the manufacturing process for styles 1073B and 1059B.
Extensive testing has been conducted by DuPont and our suppliers to verify that the modified material (Tyvek Transition Material) is functionally equivalent to the existing Tyvek material currently on the market. Further, ConMed has conducted a Risk Assessment of the change and concluded that the materials are functionally equivalent.
There are no changes to material specifications or product specifications, performance, sterilization, biocompatibility, or shelf life requirements. Neither material style numbers, catalog numbers, labeling, design nor the intended use has changed.
A list of the catalog numbers of products that utilize either 1073B or 1059B Tyvek in its packaging for ConMed, Utica and ConMed, Largo is attached to this e-mail.
Please let us know if you need any further information on this change and how it affects your markets.