# China NMPA Product Recall - Non-cemented stem

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-surgical-implants-beijing-co-ltd/b9942afb-acb1-4e9b-8123-83818b003a4f/
Source feed: China

> China NMPA product recall for Non-cemented stem by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. published April 17, 2017. Recall level: . Smith & Nephew Surgical Implants (Beijing) Co., Ltd. has initiated a voluntary recall of specific ba

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Surgical Implants (Beijing) Co., Ltd. voluntarily recalls uncemented stems
- Company Name: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Publication Date: 2017-04-17
- Product Name: Non-cemented stem
- 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. has initiated a voluntary recall of specific batches of its uncemented handles, which are critical components of cementless hip prostheses. This action, reported to the National Medical Products Administration (NMPA) in China on April 17, 2017, was prompted by a manufacturing process issue. The primary defect identified was the peeling of the vacuum plasma spray coating from the uncemented handles, with this issue observed within product packaging prior to use. Such a manufacturing flaw could potentially affect the product's performance and long-term stability in patients.

The recall encompasses various models, including A2102, A2103, A2104, A2105, and A2106, across multiple distinct batch numbers. As a required corrective action, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. disseminated written notifications to all impacted customers and distributors. These communications instructed them to halt the distribution and return all unused products from the identified problematic batches. This proactive measure ensures the removal of potentially defective medical devices from the supply chain, reinforcing product safety and adherence to NMPA's medical device quality and safety standards.

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