# 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/64c4e631-6b23-44c6-9a25-0c45778021eb/
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 liner.
- 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 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 the anti-dislocation liner might not be able to be inserted into the acetabular sleeve 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, as reported by the National Medical Products Administration (NMPA) on December 29, 2015. An internal investigation by Smith & Nephew identified dimensional deviations in certain product batches during retesting. Further inquiry traced this issue to products manufactured using Doosan machine tools between November 2014 and July 2015. The primary concern is that these dimensional inconsistencies could prevent the anti-dislocation liner from being correctly inserted into the acetabular shell during surgical procedures, potentially impacting patient safety and surgical outcomes.
Under the NMPA's regulatory oversight, the company's required actions included a comprehensive recall of all affected product models (A7143-A7149), totaling 1079 units sold in China. Smith & Nephew's Quality Department was responsible for issuing product recall notices to distributors, who in turn informed hospitals. The Supply Chain Department managed the retrieval of these affected products to the company's Shanghai warehouse, followed by their return to the Beijing manufacturing plant for appropriate processing. The company also committed to providing replacement products to distributors for the returned units. This proactive measure aimed to mitigate potential risks associated with the non-conforming surgical implants.

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