# China NMPA Product Recall - Anti-dislocation type mortis liner

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-surgical-implants-beijing-co-ltd/cf310e8a-e9c3-46ef-b024-8ef1d532ef6c/
Source feed: China

> China NMPA product recall for Anti-dislocation type mortis liner by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. published December 29, 2015. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a recall notice on December 29, 2015, 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Surgical Implants (Beijing) Co., Ltd. is voluntarily recalling its anti-dislocation acetabular liners.
- Company Name: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Publication Date: 2015-12-29
- Product Name: Anti-dislocation type mortis liner
- Recall Level: Level 3 Recall
- Recall Reason: Smith & Nephew's internal investigation revealed that during product retesting in the production process, some batches of products showed dimensional deviations. Subsequent investigations found that products manufactured using Doosan machine tools may also have dimensional deviations, posing a risk that the anti-dislocation liner might not be able to be inserted into the acetabular sleeve during surgery.
- Discovering Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Manufacturing Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) published a recall notice on December 29, 2015, regarding Smith & Nephew Surgical Implants (Beijing) Co., Ltd. The company initiated a voluntary Class III recall of its anti-dislocation ancestral liners (CFDA Registration No. 20143461204). The recall stemmed from an internal investigation that revealed dimensional deviations in certain product batches during retesting within the production process. Further investigation indicated that products manufactured using Doosan machine tools between November 2014 and 2015 were potentially affected. These deviations pose a critical risk, as the liners may not properly fit into the acetabular shell during surgical procedures, potentially impacting patient safety and surgical outcomes. To proactively mitigate these potential impacts, Smith & Nephew (Beijing) decided to recall the affected products. This action aligns with the NMPA's regulatory oversight for medical devices, ensuring product quality and safety within the healthcare system. The company provided a "Medical Device Recall Event Report Form" for detailed product specifications.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-surgical-implants-beijing-co-ltd/f23559db-e84d-4224-99a9-3b4df42a36ed/