# China NMPA Product Recall - Total Hip System

Source: https://www.globalkeysolutions.net/records/china_product_recall/microport-orthopedics-inc/01c02e31-b9bc-45af-80f0-ea8c1dbd2161/
Source feed: China

> China NMPA product recall for Total Hip System by Microport Orthopedics, Inc. published March 16, 2017. Recall level: . The National Medical Products Administration (NMPA) issued a notice on March 16, 2017, detailing a g

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MicroPort Orthopedics, Inc. is recalling its total hip system.
- Company Name: Microport Orthopedics, Inc.
- Publication Date: 2017-03-16
- Product Name: Total Hip System
- Recall Reason: MicroPort's investigation confirmed that the "BIOLOX FORTE 36mm Ceramic Femoral Head" product is approximately 2mm shorter than the MicroPort 36mm Cobalt Chrome and Biolox DELTA Ceramic femoral heads. This could ultimately lead to revision surgery due to joint laxity and/or dislocation.
- Discovering Company: Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd.
- Manufacturing Company: Microport Orthopedics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice on March 16, 2017, detailing a global voluntary recall initiated by MicroPort Orthopedics, Inc. The recall pertains to their Total Hip System, specifically the "BIOLOX FORTE 36mm Ceramic Femoral Head" component. Investigations confirmed this ceramic femoral head is approximately 2mm shorter than standard 36mm cobalt-chromium-molybdenum and Biolox DELTA ceramic femoral heads. This dimensional discrepancy poses a significant risk, potentially causing joint laxity and/or dislocation, which could necessitate revision surgery for patients. The recall falls under the NMPA's regulatory oversight, referencing medical device registration number 20153461657. While MicroPort Orthopedics, Inc. is the manufacturer, its Chinese distributor, Shanghai MicroPort Orthopedic Medical Technology Co., Ltd., confirmed that the recalled product was not sold in China. Nonetheless, the NMPA directed all provincial Food and Drug Administrations to enhance supervision and management of similar products. The required action was a global voluntary recall covering all affected batch numbers and models (26000010, 26000011, 26000012).

Company: https://www.globalkeysolutions.net/companies/microport-orthopedics-inc/f8c414bb-c564-416c-a346-277a9069d8e6/