# China NMPA Product Recall - Absorbable bone anchor system with sutures; intervention screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-mitek-sports-medicine-co-ltd/4d89084e-7b66-4bd8-87f0-2978ec4ed58c/
Source feed: China

> China NMPA product recall for Absorbable bone anchor system with sutures; intervention screws by DePuy Mitek Sports Medicine Co., Ltd. published November 18, 2019. Recall level: Level 3 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall on Nov

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its absorbable bone anchor system with sutures (intervention screws).
- Company Name: DePuy Mitek Sports Medicine Co., Ltd.
- Publication Date: 2019-11-18
- Product Name: Absorbable bone anchor system with sutures; intervention screws
- Recall Level: Level 3 Recall
- Recall Reason: The anchor components/intervention screws of specific models and batches are made of the bio-composite material BIOCRYL™, not the intended bio-composite material BIOCRYL RAPIDE™.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy Mitek Sports Medicine Co., Ltd.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall on November 18, 2019, for specific models and batches of its Suture-Integrated Absorbable Bone Anchor System (Intervention Screw). This action, reported under the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration framework, addresses a material discrepancy. The main issue was the use of BIOCRYL™ material for the anchor components/intervention screws, which deviated from the intended BIOCRYL RAPIDE™. Both materials are confirmed as biocompatible and effective for absorbable sports medicine internal fixation implants; however, the use of an unapproved material variant constitutes a product non-conformance. As a required action, the company is voluntarily recalling the affected absorbable bone anchor system with sutures (Registration Certificate No.: 20163461454) and intervention screws (Registration Certificate No.: 20173462013). Further detailed information regarding specific affected product models, specifications, and batches is available in the company's "Medical Device Recall Event Report Form." This voluntary recall demonstrates the company's commitment to product conformity and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/depuy-mitek-sports-medicine-co-ltd/2f4b4322-bf74-43eb-9d89-f30915180eeb/