# China NMPA Product Recall - Arcos Modular Revision System and accessories, Comprehensive Shoulder System

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/a9195253-85f2-4390-bbbc-9e8457129376/
Source feed: China

> China NMPA product recall for Arcos Modular Revision System and accessories, Comprehensive Shoulder System by Biomet Orthopedics published January 20, 2022. Recall level: Level 2 Recall. Biomet Orthopedics, through its reporting entity Zimmer Medical (Shanghai) International Trading Co.

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics is voluntarily recalling its Arcos Modular Revision System and Comprehensive Shoulder System, both revision femoral stems and accessories.
- Company Name: Biomet Orthopedics
- Publication Date: 2022-01-20
- Product Name: Arcos Modular Revision System and accessories, Comprehensive Shoulder System
- Recall Level: Level 2 Recall
- Recall Reason: An incorrect rework operation was performed on the porous plasma sprayed coating (PPS).
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: Biomet Orthopedics, through its reporting entity Zimmer Medical (Shanghai) International Trading Co., Ltd., has initiated a voluntary Class II recall for its Arcos Modular Revision System and Comprehensive Shoulder System (Revision Femoral Stem and Accessories). This action, published by the National Medical Products Administration (NMPA) on January 20, 2022, addresses a critical manufacturing defect. The core issue involves an incorrect rework process of the porous plasma spray (PPS) coating on specific models and batches of these orthopedic devices. Operating under the regulatory oversight of the NMPA, Biomet Orthopedics is taking proactive steps to remove the affected products from the market. While specific inspection dates are not detailed in this notice, the recall itself serves as the required action to rectify the identified product non-conformity. Detailed information regarding the affected product models, specifications, and batch numbers is accessible through the "Medical Device Recall Event Report Form" attached to the official NMPA announcement. This recall underscores the imperative for stringent quality control in medical device manufacturing to safeguard patient well-being.

Company: https://www.globalkeysolutions.net/companies/biomet-orthopedics/9bcf230e-90e5-4f4e-8673-6456e0ed8783/