# China NMPA Product Recall - Non-cemented stem (trade name: PLUS-TS)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-surgical-implants-beijing-co-ltd/0b383229-6c7f-43f6-9d0b-4ff192db2931
Source feed: China

> China NMPA product recall for Non-cemented stem (trade name: PLUS-TS) by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. published February 07, 2017. Recall level: Level 3 Recall. On February 7, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Surgical Implants (Beijing) Co., Ltd. is voluntarily recalling its uncemented stem (trade name: PLUS-TS).
- Company Name: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Publication Date: 2017-02-07
- Product Name: Non-cemented stem (trade name: PLUS-TS)
- Recall Level: Level 3 Recall
- Recall Reason: Due to a problem in the production process, Smith & Nephew received information that the vacuum plasma spray coating on a specific batch of non-cement handles had peeled off, and the peeled coating was found in the packaging before the product was used.
- Discovering Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Manufacturing Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Summary: On February 7, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. The recall pertains to their uncemented handles, identified by the trade name PLUS-TS, which are components of hip prostheses. The primary issue identified was a manufacturing process defect leading to the peeling of the vacuum plasma spray coating from specific batches of these handles. This problem was attributed to improper packaging of the product before use, with the coating detachment observed within the product packaging prior to application.

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. promptly informed affected customers in China, encompassing 4450 units across models A2301 through A2307. The required actions involve issuing written notifications to all impacted customers and retrieving all unused, affected products from distribution. This recall underscores the company's adherence to regulatory frameworks enforced by the NMPA (formerly CFDA) to ensure product quality and patient safety in medical devices.

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