China NMPA Product Recall - dental drills

Institut Straumann AG, via its subsidiary Institut Straumann (Beijing) Medical Device Trading Co., Ltd., initiated a voluntary Class III recall of its dental drill bits, as reported by the National Medical Products Administration (NMPA) on December 15, 2016. The primary issue identified was that the dental drill bits had a shank diameter of 2.35mm, which exceeded the nominal specified value. This dimensional discrepancy could prevent the drill bits from properly connecting with certain brands of dental handpieces, thereby affecting their functionality in clinical practice. The recall specifically applies to dental drill bits registered under CFDA (Imported) No. 20142550128. This action was taken proactively by Institut Straumann AG to address the product non-conformity and ensure patient safety and product performance, aligning with regulatory expectations set by the NMPA. Further detailed information regarding specific affected product models, specifications, and batch numbers was made available through the "Medical Device Recall List" attachments.