China NMPA Product Recall - Miniature locking plate system for wrist

The National Medical Products Administration (NMPA) reported a Level II voluntary recall initiated by Biomet Trauma, an international medical device manufacturer, concerning its Wrist Miniature Locking Bone Plate System. Distributed by Zimmer Medical (Shanghai) International Trading Co., Ltd., this recall was publicly noted on December 12, 2018, following a report dated November 2, 2018. The primary issue stemmed from critical labeling errors affecting two specific batches of locking screws, identified under NMPA Registration Certificate No. 20153461979. Specifically, a product package intended for a 2.7mm × 18mm locking screw (batch number 029970) was found to contain a 20mm screw, while a package labeled for a 2.7mm × 20mm locking screw (batch number 029980) contained an 18mm screw. This packaging discrepancy posed a risk of incorrect device implantation during surgical procedures. The NMPA's classification of this as a Level II recall indicates that exposure to the affected product could potentially lead to temporary or reversible adverse health consequences, though serious risks are considered remote. Despite the recall, the affected product batches were explicitly confirmed as not having been sold within the Chinese market. Therefore, no specific corrective actions were required or implemented for products within China; the recall primarily addressed products distributed in other regions, such as Japan.