# China NMPA Product Recall - Femoral stem, hip joint prosthesis - femoral stem, acetabular prosthesis, etc.

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/c6995009-d98b-4dea-945f-00e2e83a60b6/
Source feed: China

> China NMPA product recall for Femoral stem, hip joint prosthesis - femoral stem, acetabular prosthesis, etc. by HowmedicaOsteonics Corp. published September 27, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued an alert concerning a voluntary Class III

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: HowmedicaOsteonics Corp. voluntarily recalls products including femoral stems.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2017-09-27
- Product Name: Femoral stem, hip joint prosthesis - femoral stem, acetabular prosthesis, etc.
- Recall Level: Level 3 Recall
- Recall Reason: The product may have gaps in the internal and external blister packaging.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: The National Medical Products Administration (NMPA) issued an alert concerning a voluntary Class III recall initiated by Howmedica Osteonics Corp., with distribution in China managed by Stryker (Beijing) Medical Devices Co., Ltd. This recall, reported on July 31, 2017, and published on September 27, 2017, involves specific batches of femoral stem cells and other hip joint prosthesis products, including models such as Accolade TMZF and ABG-II Femoral Stem. The core issue identified was potential gaps in the internal and external blister packaging of these medical devices, which could compromise product integrity. The recall extends to various international markets, including the United States, Japan, and several European nations. However, it was confirmed that the affected product batches were not imported into China. Therefore, under the NMPA's regulatory framework, Stryker (Beijing) Medical Devices Co., Ltd. fulfilled its obligation by formally reporting the recall to the State Food and Drug Administration. No further corrective actions or product retrievals were required within China due to the absence of the impacted inventory in the local market.

Company: https://www.globalkeysolutions.net/companies/howmedicaosteonics-corp/fb8e59ba-c29a-43ec-b211-2e0a543aa1f7/