# China NMPA Product Recall - Reflection Three-Port Dual-Radius Acetabular External Cup 52mm Acetabular System (Trade Name: Reflection)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/39d575f6-d5dd-4045-b062-d48d31b47bfa/
Source feed: China

> China NMPA product recall for Reflection Three-Port Dual-Radius Acetabular External Cup 52mm Acetabular System (Trade Name: Reflection) by Smith & Nephew, Inc. Orthopedic Division published January 29, 2014. Recall level: . The National Medical Products Administration (NMPA) issued a notice on January 29, 2014, regarding a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Orthopaedic Division of the United States is recalling its acetabular system.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2014-01-29
- Product Name: Reflection Three-Port Dual-Radius Acetabular External Cup 52mm Acetabular System (Trade Name: Reflection)
- Recall Reason: Errors during the manufacturing process resulted in a smaller-than-expected radius of the spherical inner part of the acetabular outer cup.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew, Inc. Orthopedic Division
- Summary: The National Medical Products Administration (NMPA) issued a notice on January 29, 2014, regarding a recall initiated by Smith & Nephew, Inc. Orthopaedic Division. The recall, reported by its representative Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. on January 27, 2014, pertained to the company's Reflection Three-Port Dual-Radius Acetabular Cup 52mm Acetabular Systems. The core issue stemmed from a manufacturing error that resulted in the internal spherical radius of the acetabular outer cup being smaller than expected. This defect specifically impacted products identified by Model 71336052, Lot No. 13EM03053, which are designed for use as cementless hip joint prostheses in hip replacement procedures. Operating under the NMPA's regulatory oversight, Smith & Nephew, Inc. voluntarily initiated the recall. A significant detail is that the affected product batches were not imported into China, meaning there was no direct impact on the Chinese market. Consequently, the primary action involved managing the recall in the regions where the product was distributed, such as the United States. The NMPA also instructed provincial and municipal food and drug administrations to enhance their supervision and management of similar medical devices.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc-orthopedic-division/82243c50-18e1-44ef-893f-7042c1105847/