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

On April 29, 2021, Smith & Nephew Orthopaedics Ltd., via its reporting entity Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., announced a voluntary Class II recall of its BIRMINGHAM HIP Manual Instrument for Hip Surgery. This significant action stems from a detected manufacturing error impacting specific models and batches of the instrument. The core issue involves the inability of the tool to correctly connect with the drill adapter, which is critical for the proper execution of hip surgery. Such a malfunction could potentially compromise surgical efficacy and patient safety during an orthopedic procedure.

The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) and is formally registered with Recordation No. 国械备20160917号. A Class II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote. Smith & Nephew's required action involves identifying and retrieving the affected instruments to prevent their further use and to address the underlying manufacturing defect. This demonstrates the company's adherence to regulatory standards and its commitment to ensuring the reliability and safety of medical devices distributed within the NMPA's jurisdiction.