# China NMPA Product Recall - Exceed ABT Acetabular System

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-uk-limited/b7cac34c-3fc1-4b15-9efa-9c73ac4cffea/
Source feed: China

> China NMPA product recall for Exceed ABT Acetabular System by Biomet UK Limited published September 18, 2020. Recall level: Level 2 Recall. On September 18, 2020, the National Medical Products Administration (NMPA) announced a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet UK Limited is voluntarily recalling the Exceed ABT Acetabular System hip prosthesis.
- Company Name: Biomet UK Limited
- Publication Date: 2020-09-18
- Product Name: Exceed ABT Acetabular System
- Recall Level: Level 2 Recall
- Recall Reason: There is a mismatch between the etching on the product and the size on the label for certain models and batches of products.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet UK Limited
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/biomet-uk-limited/bad0cf22-37ea-453b-8c51-901d5eef5775/