China NMPA Product Recall - Exceed ABT Acetabular System

On September 18, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Biomet UK Limited for its Exceed ABT Acetabular System Hip Prosthesis. The recall was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. and stems from a critical labeling discrepancy where the etching on certain product models and batches did not match the size indicated on the product label. This identification error could lead to incorrect product usage or patient safety concerns.

Operating under the NMPA's regulatory oversight, Biomet UK Limited is undertaking this recall to address the non-conformance. A Class II recall signifies a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Affected product models, specifications, and batch numbers are detailed in the "Medical Device Recall List" and an accompanying "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks associated with the mislabeled hip prostheses and ensure patient safety.