# 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/8f7778b6-28ef-4213-a045-18ebee0439bc/
Source feed: China

> China NMPA product recall for Non-cemented stem (trade name: PLUS-TS) by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. published April 17, 2017. Recall level: Level 3. Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Level III recall for spec

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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: 2017-04-17
- Product Name: Non-cemented stem (trade name: PLUS-TS)
- Recall Level: Level 3
- Recall Reason: Due to a problem in the manufacturing process, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. is voluntarily recalling a specific batch of uncemented stems. Smith & Nephew received information that the vacuum plasma spray coating on a specific batch of uncemented stems had peeled off; 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: Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Level III recall for specific batches of its uncemented handles, branded as PLUS-TS, used in hip prostheses. The recall, reported on February 6, 2017, and published by the National Medical Products Administration (NMPA) on April 17, 2017, was prompted by a manufacturing process issue. It was discovered that the vacuum plasma spray coating on certain uncemented handles had peeled off while still in the product packaging, prior to use. This issue affected 4450 units sold or imported into China, encompassing various models from A2301 to A2307. A Level III recall signifies that the use of, or exposure to, the affected product is not likely to cause adverse health consequences. In response, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. implemented corrective actions by sending written notifications to all affected customers, requesting the return of any unused products. This proactive measure was taken under the regulatory framework overseen by the NMPA, previously known as the China Food and Drug Administration (CFDA), as detailed in the CFDA Approval No. 20143461197.

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