# China NMPA Product Recall - Joint surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/74c0437a-79fe-40f9-8b43-18416b50a843/
Source feed: China

> China NMPA product recall for Joint surgical tools by HowmedicaOsteonics Corp. published September 14, 2016. Recall level: Level 3 Recall. Howmedica Osteonics Corp., through its reporting unit Stryker (Beijing) Medical Devices Co., Ltd., i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. initiates voluntary recall of joint surgery tools
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2016-09-14
- Product Name: Joint surgical tools
- Recall Level: Level 3 Recall
- Recall Reason: The factory received a report regarding threaded lengths protruding from the acetabular mold or implant dome. An investigation determined that the indentation between the stud and handle shaft of the acetabular cup inserter tool could cause the stud to gradually protrude over time.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: Howmedica Osteonics Corp., through its reporting unit Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its joint surgical instruments. The recall, publicly reported on September 14, 2016, addresses a critical issue with the acetabular cup inserter. An investigation revealed that the indentation between the stud and the handle shaft assembly of this instrument may lead to the stud gradually protruding over time. This defect could result in threaded sections emerging from the acetabular mold or implant dome during use.
The affected products, which include various models and specifications used in hip, knee, shoulder, elbow, and wrist arthroplasty, were distributed globally, with 217 units sold in China. The regulatory framework for this action falls under the National Medical Products Administration (NMPA) and its associated CFDA (Imported) registration. As a required action, Howmedica Osteonics Corp. notified all affected distributors of the specific product batches involved, instructing them to return the implicated instruments to the original manufacturer for proper disposal. The recall emphasizes the company's commitment to product safety and compliance with medical device regulations.

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