# China NMPA Product Recall - Orthopedic surgical instruments - medullary reamer, perfusion, and suction system (trade name: RIA)

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/2d437de3-d509-4ade-b92b-32603ae501f6/
Source feed: China

> China NMPA product recall for Orthopedic surgical instruments - medullary reamer, perfusion, and suction system (trade name: RIA) by Synthes GmbH published December 22, 2014. Recall level: . On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., in coordination with m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its orthopedic surgical instruments – the reamer, perfusion, and suction system (trade name: RIA).
- Company Name: Synthes GmbH
- Publication Date: 2014-12-22
- Product Name: Orthopedic surgical instruments - medullary reamer, perfusion, and suction system (trade name: RIA)
- Recall Reason: The manufacturer discovered that the expiration date stated on the relevant product labels was incorrect. Current stability data only supports a 2-year shelf life from the date of manufacture, but the affected products on the market are incorrectly labeled with a 10-year shelf life. Currently available biocompatibility testing data only supports a 2-year shelf life; biocompatibility testing to support a 10-year shelf life has not yet been completed. Although there is no evidence that the device will cause cytotoxicity beyond its expiration date, the lack of supporting data theoretically suggests that this risk exists.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: On December 22, 2014, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., in coordination with manufacturer Synthes GmbH, initiated a voluntary Class 1 recall of specific Orthopedic Surgical Instruments: the Reaming, Perfusion, and Suction System (Trade Name: RIA). This regulatory action was overseen by the National Medical Products Administration (NMPA) of China. The core issue identified was a discrepancy in the product's labeled expiration date. Stability and biocompatibility data only supported a two-year validity period from the manufacturing date, yet affected products were incorrectly labeled with a ten-year shelf-life. While no direct evidence confirmed adverse events, a theoretical risk of cytotoxicity after the two-year period was acknowledged due to insufficient data supporting the extended duration. The recall involved specific models, including 314.745S, 352.260S, and 357.718.02S, with 25 units imported into China. Crucially, all affected products were intercepted after import and had not been sold within the Chinese market, minimizing potential patient exposure. The required action was a comprehensive voluntary recall to rectify the mislabeling and ensure product validity aligns with scientific evidence.

Company: https://www.globalkeysolutions.net/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7/