# China NMPA Product Recall - Joint surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/10d584ea-6723-46cd-b12d-e0f505bacbc2/
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., in collaboration with Stryker (Beijing) Medical Devices Co., Ltd., initia

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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: Over time, the press fit between the stud and the handle shaft assembly of the acetabular cup inserter may cause the stud to gradually protrude.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: Howmedica Osteonics Corp., in collaboration with Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its joint surgical instruments. This action was reported to the National Medical Products Administration (NMPA) on August 31, 2016, and publicly announced on September 14, 2016. The recall pertains to specific joint surgical instruments (CFDA (Imported) 2013 No. 1104594), which are utilized in various arthroplasty procedures for hip, knee, shoulder, elbow, and wrist. The primary issue identified is the potential for the stud between the stud and handle shaft assembly of the acetabular cup inserter to gradually protrude over time. This defect may lead to threaded sections appearing from the acetabular mold or implant dome. The recall affects 217 units distributed in China, as part of a global recall. To address this, Howmedica Osteonics Corp. is required to notify all affected distributors, instructing them to return the impacted product batches to the manufacturer for appropriate disposal, thereby mitigating any potential risks associated with the faulty instruments.

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