China NMPA Product Recall - G7 Acetabular System artificial hip joint, E1 Acebabular Liners, G7 OsseoTi Acetabular Shell artificial hip joint components - acetabular cup and accessories

The National Medical Products Administration (NMPA) announced on November 14, 2022, a Class II voluntary recall initiated by Biomet Orthopaedic Corporation. This action concerns several artificial hip joint components, specifically the G7 Acetabular System, E1 Acetabular Liners, and G7 OsseoTi Acetabular Shell components. The issue, reported by Zimmer Medical (Shanghai) International Trading Co., Ltd., stems from a potential risk of the thin corner wall of the outer sterile blister packaging cracking during product transportation. This packaging defect could compromise the sterility of the medical devices. The recall impacts specific models and batches of these crucial orthopedic implants, identified by Registration Certificate Nos.: 20153463499, 20163131540, and 20203130387. The NMPA is the regulatory authority overseeing this recall, indicating adherence to medical device safety standards. As part of the required actions, Biomet Orthopaedic Corporation has initiated this voluntary recall to address the packaging integrity concern. Further detailed information, including specific product models, specifications, and affected batches, is documented in the "Medical Device Recall Event Report Form," which is available as an attachment to the NMPA announcement. This measure ensures patient safety by preventing potentially compromised products from reaching the market.