# China NMPA Product Recall - Knee revision prosthesis

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/90b65522-984f-4af3-a0a8-61594411a7cd/
Source feed: China

> China NMPA product recall for Knee revision prosthesis by HowmedicaOsteonics Corp. published August 19, 2019. Recall level: Level 2 Recall. Howmedica Osteonics Corp., represented by its agent Stryker (Beijing) Medical Devices Co., Ltd., ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. voluntarily recalls knee revision prostheses.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2019-08-19
- Product Name: Knee revision prosthesis
- Recall Level: Level 2 Recall
- Recall Reason: Stryker discovered that specific models and batches of distal femoral pads protrude beyond the medial edge of the matching femoral assembly. (The distal femoral pads are available in only four models: size 2 (left 10mm), size 2 (right 10mm), size 2 (left 15mm), and size 2 (right 15mm). These distal femoral pads can be used in conjunction with the Triathlon TS femoral assembly during revision total knee arthroplasty, or in conjunction with the Triathlon PS femoral assembly during primary total knee arthroplasty.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: Howmedica Osteonics Corp., represented by its agent Stryker (Beijing) Medical Devices Co., Ltd., initiated a global Class II recall for specific models and batches of its knee revision prostheses (NMPA Registration Certificate No. 20173466930). This action, reported on August 15, 2017, stemmed from the discovery that certain distal femoral pads—specifically four models (Size 2 left/right 10mm, Size 2 left/right 15mm)—protruded beyond the medial edge of their corresponding femoral components. These components are used in both revision and primary total knee arthroplasty. Under the regulatory framework of the National Medical Products Administration (NMPA), Howmedica Osteonics Corp. was required to implement corrective measures. In China, 35 affected distal femoral implants were identified. As all units remained in stock and had not been sold or distributed to users or healthcare facilities, no customer notification letters were necessary. The required action was to return these 35 implants to the manufacturing plant for proper disposal, ensuring no affected products reached the market.

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