# China NMPA Product Recall - Non-cemented stem

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-surgical-implants-beijing-co-ltd/126daf78-12ce-48ac-be40-4267c07e101a/
Source feed: China

> China NMPA product recall for Non-cemented stem by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. published November 23, 2016. Recall level: Level 3 Recall. Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Class III recall of speci

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Surgical Implants (Beijing) Co., Ltd. is voluntarily recalling its non-cemented stems.
- Company Name: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Publication Date: 2016-11-23
- Product Name: Non-cemented stem
- Recall Level: Level 3 Recall
- 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 Class III recall of specific batches of its uncemented handles, components used in cementless hip prostheses. The National Medical Products Administration (NMPA) published this recall notice on November 23, 2016, based on the company's report dated November 16, 2016. The recall was prompted by a manufacturing process issue resulting in the peeling of the vacuum plasma spray coating on these devices. This critical defect was observed within the product packaging before use, raising concerns about product integrity. The recall impacts 169 units of affected products in China, specifically models A2104 and A2105, identifiable by various batch numbers including 16AB00351 and 16CB00614. Operating under the regulatory oversight of the NMPA, which references CFDA Approval No. 20143461200, the company's required action involved sending written notifications to all affected customers. These notifications requested the return of any unused defective products, aiming to mitigate potential risks and uphold medical device quality standards.

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