# 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/a7ea766b-01a4-4bea-8636-3a0b3aa72e90/
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. On December 29, 2015, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. announced a voluntary Cla

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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 found that some batches of products had dimensional deviations during retesting during the production process. Subsequent investigations revealed that products manufactured by Doosan machine tools between November 2014 and 2015 may have had deviations, posing a risk that the anti-dislocation liner could not be inserted into the acetabular cover during surgery.
- Discovering Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Manufacturing Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Summary: On December 29, 2015, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. announced a voluntary Class III recall of certain batches of its Anti-Dislocation Ancestral Liners. This action was taken after an internal investigation revealed dimensional deviations during product retesting within the production process. The subsequent inquiry identified that medical devices manufactured between November 2014 and 2015, specifically those produced using Doosan machine tools, were likely affected by these inconsistencies. The primary concern arising from these dimensional deviations is the critical risk that the anti-dislocation liner may not properly fit or be inserted into the acetabular shell during orthopedic surgery. Such a malfunction could lead to significant complications and compromise surgical outcomes. To proactively address and prevent any potential patient impact, Smith & Nephew chose to initiate this recall. The company's immediate response, operating under the oversight of the National Medical Products Administration (NMPA), underscores its commitment to product safety and regulatory compliance. Further specific details regarding the models and specifications of the recalled medical devices are provided in the company's Medical Device Recall Event Report Form.

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