# China NMPA Product Recall - Non-cemented stem

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-surgical-implants-beijing-co-ltd/c72786fd-21c9-493a-89a5-c00d7df43679/
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 for spec

---

## 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: The vacuum plasma spray coating on a specific batch of non-cement handles has peeled off; the peeled coating was found in the packaging before product use.
- 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 for specific batches of its uncemented handles, as reported by the National Medical Products Administration (NMPA) on November 23, 2016. The recall was prompted by the discovery of peeling vacuum plasma spray coating on the affected devices, with the defect identified within the product packaging before clinical use. While specific inspection dates are not detailed in the provided document, the company proactively reported the manufacturing issue. The main issue was the compromised integrity of the coating on the uncemented handles, which could potentially impact the product's performance or safety. Operating under the regulatory framework of the NMPA, Smith & Nephew Surgical Implants (Beijing) Co., Ltd. is required to identify and retrieve all affected products from the market. The recall event, pertaining to products registered under CFDA Approval No. 20143461200, includes a detailed 'Medical Device Recall Event Report Form' specifying the affected models, specifications, and batch numbers to facilitate the recovery process. This action highlights the company's commitment to ensuring product quality and patient safety within the medical device sector in China.

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