# China NMPA Product Recall - Tendon and ligament fixation anchors

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-products-international-trading-shanghai-co-ltd/3204ea99-6158-43de-86c0-c984c5841b1a/
Source feed: China

> China NMPA product recall for Tendon and ligament fixation anchors by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published March 30, 2020. Recall level: Level 2 Recall. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Lev

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is voluntarily recalling tendon and ligament fixation anchors.
- Company Name: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-03-30
- Product Name: Tendon and ligament fixation anchors
- Recall Level: Level 2 Recall
- Recall Reason: Excessive space between the product and its packaging may cause the protective cap on the product tip to shift due to excessive product movement. This could result in the product tip puncturing the sterile packaging.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its tendon and ligament fixation anchors, published on March 30, 2020, through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by an identified issue where excessive space between the medical device and its internal packaging could allow for increased product movement. This movement posed a risk that the protective cap at the product's tip might shift and potentially puncture the sterile packaging. A compromised sterile barrier could render the device unsuitable for its intended surgical application, although the company noted that this specific defect is easily detectable prior to use. This proactive measure by Smith & Nephew demonstrates their commitment to patient safety and adherence to the regulatory framework established by the NMPA. The required action involves removing all affected batches of these anchors from the market to mitigate any potential risks, with specific models and batches detailed in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/smith-nephew-medical-products-international-trading-shanghai-co-ltd/838e3e3f-d561-4f82-9b98-419473c58276/