China NMPA Product Recall - dental drills

Institut Straumann AG, in collaboration with its subsidiary Straumann (Beijing) Medical Device Trading Co., Ltd., initiated a voluntary Class III recall for specific models of its dental drill bits. The recall, reported on December 7, 2016, and published by the National Medical Products Administration (NMPA) on December 15, 2016, stemmed from a manufacturing deviation. The main issue identified was that the shank diameter of the affected drill bits measured 2.35mm larger than its nominal value. This dimensional discrepancy could prevent proper connection with certain brands of dental handpieces, potentially compromising their intended use in oral implantation procedures for the Straumann dental implant system. Operating under the regulatory framework of CFDA (Imported) No. 20142550128, the company confirmed that all affected products, encompassing models such as 044.210, 044.214, 044.215, and 044.255, had not yet entered the market and remained within the company's warehouse. The required action involves transferring all involved inventory to a dedicated isolation area under supervision, followed by their central destruction. The entire destruction process will be documented with photographic evidence to ensure proper handling and compliance.