# China NMPA Product Recall - Acetabular external cup system XLPE acetabular pad (R3 20° high edge 36 mm ID×60mm OD and R3 20° high edge 36 mm IDX62mm OD)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/6dc64f7e-42e6-4af8-9bbb-841dddf8991e/
Source feed: China

> China NMPA product recall for Acetabular external cup system XLPE acetabular pad (R3 20° high edge 36 mm ID×60mm OD and R3 20° high edge 36 mm IDX62mm OD) by Smith & Nephew, Inc. Orthopedic Division published June 19, 2013. Recall level: . On June 19, 2013, the National Medical Products Administration (NMPA) in China issued a notice conce

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Orthopaedics Division is recalling acetabular liners.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2013-06-19
- Product Name: Acetabular external cup system XLPE acetabular pad (R3 20° high edge 36 mm ID×60mm OD and R3 20° high edge 36 mm IDX62mm OD)
- Recall Reason: Due to an internal process error, an investigation revealed that products with an R3 20° 36 mm ID XLPE acetabular liner and a 60 mm OD were laser-engraved as 20° 36 mm ID XLPE acetabular liner with a 62 mm OD; while products with an R3 20° 36 mm ID XLPE acetabular liner and a 62 mm OD were laser-engraved as R3 20° 36 mm ID XLPE acetabular liner with a 60 mm OD.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew, Inc. Orthopedic Division
- Summary: On June 19, 2013, the National Medical Products Administration (NMPA) in China issued a notice concerning a voluntary recall initiated by Smith & Nephew, Inc. Orthopaedics Division, reported by its local subsidiary Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The recall, dated May 31, 2013, addressed labeling errors found on specific R3 XLPE acetabular liners (models 71335760 and 71335762, batch numbers including 12FM00602 and 12FM00603). The core issue was that some liners with a 62mm outer diameter (OD) were incorrectly laser-engraved with a 60mm OD. These liners are critical components for hip replacement surgeries. The recall affected multiple international regions, including parts of Europe, North America, South America, the Middle East, and Africa. While the NMPA requested its provincial food and drug regulatory departments to strengthen supervision, the official report confirmed that the recalled batches of acetabular liners were not imported into China. Therefore, no direct product-related actions are required within the Chinese market, as the issue had no impact there.

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