China NMPA Product Recall - Dental implants

Zimmer Dental Inc., in conjunction with its agent Jiemei (Shanghai) Medical Device Co., Ltd., initiated a voluntary Class II recall of specific dental implants, including Tapered Screw-Vent models. The National Medical Products Administration (NMPA) publicized this recall on May 7, 2019. The issue arose from significant labeling discrepancies reported by overseas customers. An internal investigation by Zimmer Dental Inc. revealed that different batches of Tapered Screw-Vent implants were partially mixed during assembly, resulting in incorrect product labeling. Affected products included models like TSV4B10 and TSVTB10, with batch number 63619437 specifically noted.

While the recall encompassed numerous international regions such as Japan, Costa Rica, and several European nations, Zimmer Dental Inc. confirmed that the identified affected batches were not distributed or sold within the Chinese market. Therefore, the NMPA has not required any additional corrective actions or recall procedures for products in China. The incident, reported on April 4, 2019, was communicated to the NMPA for informational purposes only. This voluntary action reflects Zimmer Dental Inc.'s adherence to product quality standards and regulatory compliance, mitigating potential risks associated with mislabeled medical devices globally.