China NMPA Product Recall - Orthopedic Instruments

Arthrex, Inc., a manufacturer of orthopedic surgical instruments, has initiated a voluntary recall of specific orthopedic devices due to an identified labeling error. The recall, reported by Arthrex Medical Devices (Shanghai) Co., Ltd., was announced by the National Medical Products Administration (NMPA) on October 23, 2023. The primary issue involves an incorrect sterilization marking present on the English label of the affected products, specifically Orthopedic Instruments with the identifier 20212040521. This mislabeling has led to a Class III recall, indicating a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The regulatory framework overseeing this action is the National Medical Products Administration of China, which published the recall notice. While specific inspection dates are not detailed in the provided document, the recall itself is a proactive measure undertaken voluntarily by Arthrex, Inc. The required action involves the withdrawal of the incorrectly labeled orthopedic surgical instruments from the market. Comprehensive details regarding the affected product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form," an attachment referenced in the NMPA notice. This recall ensures that medical professionals and patients receive accurately labeled products, upholding safety standards for surgical instruments.