
Medical Device R&D and Manufacturer

01

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported that due to sterilization issues with certain batches of products, the manufacturer Synthes GmbH has initiated a voluntary recall of its Intramedullary Nailing System (Registration No. 20163461197), Orthopedic (Surgical) Instruments - Reamer Irrigator Aspirator (RIA) System (Registration No. 20172101087), Metallic Intramedullary Nailing System (Registration No. 20213130542), and OPAL Interbody Fusion Device (Registration No. 20173461981). The recall is classified as a Level III recall.



02

Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported that due to reasons such as the expiration date of a reagent component in a certain batch number kit being inconsistent with the expiration date of the entire kit, the manufacturer Beckman Coulter, Inc. (USA) voluntarily recalled its Unsaturated Iron Binding Capacity Assay Kit (Nitroso-PSAP method) UIBC (Registration Certificate for Imported Medical Devices: 20142405086). The recall level is classified as a Level Three recall.



03

Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported that due to issues such as the pipette tip of the aliquoting module of the involved product entering too deeply into the original sample tube, penetrating the gel, and potentially causing overflow of the original sample, Beckman Coulter Biomedical GmbH, the manufacturer, voluntarily initiated a recall of its fully automated sample processing system DxA Automation System (Registration No. 20181379). The recall level is classified as a Level 2 recall.



04

Ivoclar Vivadent (Shanghai) Trading Co., Ltd. reported that due to errors in the production process, the light intensity of the affected LED light curing units exceeded the standard. The manufacturer, Ivoclar Vivadent AG, voluntarily recalled its LED light curing units (China Medical Device Registration No. 20172556837). The recall level is classified as a Level Three recall.




