# 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/758a597f-b360-47b4-a38a-bc3c8acf2b16/
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) announced a Class III voluntary recall initiated

---

## 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 inner and outer blister packaging.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Howmedica Osteonics Corp., the manufacturer of various femoral stems and hip joint prostheses. Reported by Stryker (Beijing) Medical Devices Co., Ltd. on July 31, 2017, the recall addresses potential gaps in the internal and external blister packaging of products such as the Accolade TMZF Femoral Stem, ABG-II Femoral Stem Joint Prosthesis, and Restoration Hip Joint Prosthesis. This packaging defect raised concerns about product integrity. While the recall is broad, impacting countries including Canada, Japan, Australia, the US, and several European nations, Stryker (Beijing) confirmed that no affected batches of these medical devices were imported into China. Therefore, the required action for the Chinese agent was limited to reporting the recall to the State Food and Drug Administration, with no further local corrective measures or product retrievals necessary within China, due to the absence of the impacted products in the domestic market.

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