China NMPA Product Recall - Metal bone screws

Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., acting on behalf of Zimmer Inc., initiated a voluntary Class III recall of specific batches of metal bone screws. This recall was reported to the National Medical Products Administration (NMPA) in May 2016 and publicly announced in July 2016. The affected products include certain models of Herbert 6.5mm Hollow Bone Screws (45mm, 75mm, and 90mm lengths) that were manufactured between February and March 2016 and subsequently released from March to April 2016. The main issue identified was a defect in the inner packaging material of the double sterile packaging, specifically minor damage to the inner plastic blister pack. Despite this, assessments confirmed that the outer blister pack remained intact, thereby maintaining the product's sterility until the outer packaging is opened. It is estimated that less than 10% of the affected products exhibited this damage. As a required action, all frozen inventory of the implicated products has been returned to the manufacturer, Zimmer Inc. Importantly, no complaints, adverse events, or deaths related to this specific packaging issue have been reported domestically or globally to date, highlighting a proactive measure by the company to ensure product quality and patient safety under NMPA oversight.