# China NMPA Product Recall - Arcos Modular Revision System (Femoral Stem and Accessories)

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/267f93c9-28e1-47c7-809a-50e5dd32a2e7/
Source feed: China

> China NMPA product recall for Arcos Modular Revision System (Femoral Stem and Accessories) by Biomet Orthopedics published June 22, 2021. Recall level: . Biomet Orthopedics, via Zimmer Medical (Shanghai) International Trading Co., Ltd., has initiated a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics is voluntarily recalling its Arcos Modular Revision System revision femoral stem and accessories.
- Company Name: Biomet Orthopedics
- Publication Date: 2021-06-22
- Product Name: Arcos Modular Revision System (Femoral Stem and Accessories)
- Recall Reason: The product's inner tapered surface has chatter marks due to a mismatch in the boring bar during manufacturing.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: Biomet Orthopedics, via Zimmer Medical (Shanghai) International Trading Co., Ltd., has initiated a voluntary recall of specific models and batches of its Arcos Modular Revision System (Revision Femoral Stem and Accessories). This action, announced by the National Medical Products Administration (NMPA) on June 22, 2021, addresses a manufacturing flaw where a mismatch in the boring bar during production resulted in a "chatter mark" on the inner conical surface of the product. This defect has the potential to compromise the device's performance and patient safety. Under the regulatory framework of the NMPA, Biomet Orthopedics is undertaking this recall to retrieve the affected medical devices. Detailed information, including specific registration certificate numbers (e.g., 20163461304, 20163131304) and batch numbers, is provided in a Medical Device Recall Event Report Form. This proactive measure ensures the manufacturer's compliance with quality standards and aims to mitigate potential risks associated with the identified product integrity issue.

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