China NMPA Product Recall - Knee components

Biomet Orthopedics, through its Chinese responsible unit Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. (also referred to as Bangmei (Shanghai) Trading Co., Ltd.), initiated a voluntary Level II recall of specific batches of its Vanguard PS open-box femoral condyle prostheses. The recall, reported to the National Medical Products Administration (NMPA) on January 7, 2017, and published on February 21, 2017, addresses a critical labeling error. The primary issue involved incorrect product packaging labels, where some femoral condyle prostheses were erroneously marked with the wrong size (smaller or larger) or side (right/left). This problem stemmed from inadequate supplier clearance procedures identified between April 5, 2016, and September 1, 2016. While the estimated incidence rate was low at 0.001%, the potential for patient harm necessitated this action. Operating under the NMPA’s medical device recall framework (formerly CFDA), Biomet Orthopedics promptly recalled 3301 affected units globally, with 2322 units sold in China. The required action involved retrieving all unused affected products, which have since been successfully returned to the manufacturer. Fortunately, no adverse events or related complaints in China were reported concerning this labeling discrepancy.