China NMPA Product Recall - craniofacial bone screws

On September 13, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Synthes GmbH, concerning specific craniofacial bone screws. This recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the distributor of these products in China. The primary issue leading to the recall was a significant discrepancy between the product contained within the packaging and its corresponding label. This mislabeling affected models 04.511.226.04S, 04.511.635.04S, and 04.511.666.04S, across various batch numbers. These screws are critical components used for internal fixation in craniofacial orthopedic surgery, facilitating temporary stabilization during bone healing. Operating under the regulatory oversight of the NMPA and referencing the CFDA (Imported) product registration, Synthes GmbH took proactive steps to initiate this recall. However, the accompanying 'Medical Device Recall Event Report Form' explicitly clarifies that none of the affected product batches were imported into China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that no corrective actions or product retrievals are mandated or required within the Chinese market for this particular recall event. The reporting date for this incident was August 7, 2017.