China NMPA Product Recall - Joint surgical tools

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Howmedica Osteonics Corp. for its manufactured joint surgical tools, registered under CFDA (Imported) No. 20131104042. The recall, published on August 19, 2016, was prompted by reports received by Stryker (Beijing) Medical Devices Co., Ltd., detailing four instances where patellar forceps tool components separated. An investigation into these incidents confirmed that the press-fit between the bone pin and the clamping sub-component did not meet required specifications, indicating a manufacturing defect that could compromise device integrity during use. In response to these findings, Howmedica Osteonics Corp. undertook a voluntary recall of the affected products. A Class III recall typically signifies a situation where the use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has advised that detailed information concerning the specific affected product models and sub-items can be found in the "Medical Device Recall Event Report Form."