# 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/843db00a-63c3-4cb6-865e-0ce81a90c5f2/
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. Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Class III recall of its A

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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: Some batches of products have dimensional defects, posing a risk that the anti-dislocation liner may 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: Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Class III recall of its Anti-Dislocation Ancestral Liners (CFDA Registration No. 20143461204) following an internal investigation. The company discovered dimensional deviations in certain product batches manufactured between November 2014 and 2015 using Doosan machine tools. This manufacturing defect presents a critical risk: the anti-dislocation liner may not properly insert into the acetabular shell during surgical procedures, potentially impacting patient safety and surgical outcomes. To mitigate these potential impacts, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. proactively decided to recall all affected products. The recall was reported and managed under the regulatory oversight of the National Medical Products Administration (NMPA), ensuring adherence to medical device safety standards. Detailed information regarding specific affected product models and specifications is available in the accompanying "Medical Device Recall Event Report Form".

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