# China NMPA Product Recall - BIRMINGHAM HIP Manual Instrument for Hip Surgery

Source: https://www.keypedia.com/records/china_product_recall/smith-nephew-surgical-implants-beijing-co-ltd/449e1870-1325-4c1c-9017-870cc782f2ff
Source feed: China

> China NMPA product recall for BIRMINGHAM HIP Manual Instrument for Hip Surgery by Smith & Nephew Surgical Implants (Beijing) Co., Ltd. published July 27, 2021. Recall level: Level 2 Recall. Smith & Nephew Surgical Implants Ltd. has voluntarily initiated a Class II recall for its BIRMINGHAM

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Surgical Implants Ltd. of the UK has initiated a voluntary recall of its BIRMINGHAM HIP Manual Instrument for hip surgery.
- Company Name: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Publication Date: 2021-07-27
- Product Name: BIRMINGHAM HIP Manual Instrument for Hip Surgery
- Recall Level: Level 2 Recall
- Recall Reason: Because specific models and batches of products were involved, and some were manufactured using specifications not approved by Smith & Nephew, the connection methods of these square-headed nails differed.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Surgical Implants (Beijing) Co., Ltd.
- Summary: Smith & Nephew Surgical Implants Ltd. has voluntarily initiated a Class II recall for its BIRMINGHAM HIP Manual Instrument, a device intended for hip surgery. This recall, published on July 27, 2021, is overseen by the National Medical Products Administration (NMPA), the primary regulatory body responsible for medical devices in China. The provided document does not specify inspection dates; instead, it focuses on the recall event itself.

While the public announcement does not elaborate on the specific issues or violations that prompted this action, a Class II recall typically addresses situations where a product defect could lead to temporary or reversible adverse health consequences, or where the likelihood of serious harm is remote. The company has made detailed information regarding affected models, specifications, and batch numbers available in a 'Medical Device Recall Event Report Form.' This form serves as the official record for the incident and outlines the required actions for healthcare providers and distributors to identify, quarantine, and return or manage the recalled instruments. Smith & Nephew is expected to ensure full compliance with NMPA's regulatory requirements throughout this recall process, prioritizing patient safety and product integrity.

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