China NMPA Product Recall - Joint surgical tools
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The National Medical Products Administration (NMPA) announced a recall on April 10, 2012, for joint surgical tools manufactured by Howmedica Osteonics Corp. This voluntary recall, reported by Stryker (Beijing) Medical Devices Co., Ltd. on March 16, 2012, addresses a potential risk of breakage during use, specifically involving the Accolade bone reamer handle. These instruments are designed for various arthroplasty and trauma surgeries. Under the NMPA's regulatory guidance, Howmedica Osteonics Corp. initiated the recall. Crucially, the company confirmed that no affected products (Model/Specification: 1020-1400) were sold or imported into the Chinese market, meaning China is not directly impacted and will not submit a recall implementation report. The recall primarily involves countries such as Canada, the UK, Japan, Australia, and several others. Chinese provincial and municipal food and drug administrations were nevertheless advised to enhance their supervision and management of similar medical devices, underscoring the NMPA's commitment to patient safety.
- Company
- HowmedicaOsteonics Corp.
ID · e4429928-0db1-4714-ac9b-857b1f9223b4