# 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/9173f8e1-67f2-47a2-bd67-6a00ac743911/
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. 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 Reason: Smith & Nephew's internal investigation revealed that dimensional deviations in some batches of products were found during retesting during the production process. Subsequent investigations found that products manufactured using Doosan machine tools between November 2014 and July 2015 may also have dimensional deviations, posing a risk that anti-dislocation liner might not be able to be inserted into the surgical hood during surgery. To avoid potential impacts, the company decided to recall these batches of products.
- 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 Approval No. 20143461204) under the oversight of the National Medical Products Administration (NMPA). An internal company investigation, published on December 29, 2015, identified significant dimensional deviations during retesting of certain product batches. Further inquiry revealed that products manufactured between November 2014 and July 2015, specifically those produced using Doosan machine tools, were susceptible to these deviations. This critical issue presented a risk that the anti-dislocation liner might not be able to be inserted into the acetabular shell during surgical procedures. To mitigate potential patient impact, the company implemented a comprehensive recall plan for affected models (A7143-A7149). This involved the Quality Department issuing recall notices to distributors and hospitals. All affected products, totaling 1139 units produced, were to be retrieved from the market and returned to Smith & Nephew's Shanghai warehouse, then transported to the Beijing manufacturing plant for processing. The company also committed to providing corresponding replacement products to distributors for the returned quantities.

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