China NMPA Product Recall - Interbody fusion device

Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., representing manufacturer Zimmer Spine, initiated a voluntary Class II recall of intervertebral fusion devices. This action was reported to the National Medical Products Administration (NMPA) on March 7, 2016, and publicly announced on April 21, 2016. The recall was prompted by a significant product mix-up: an opened package identified as product number SN3001-0-31404 (batch M1869208) was discovered to contain the contents of product number SN3001-0-31100 (batch M1869204). This issue created a potential for confusion between these two distinct product batches. The affected products are Posterior Thoracolumbar Fusion Cages, with 167 units of SN3001-0-31100 and 82 units of SN3001-0-31404 having been imported into China, impacting global regions. In compliance with the NMPA's medical device regulatory framework, Zimmer Medical is required to retrieve all unused products from the two specified batches. These items must be returned to Zimmer Spine, the manufacturer, to rectify the mislabeling and uphold product integrity and patient safety.