# China NMPA Product Recall - Intramedullary nailing system; orthopedic surgical instruments - reamer, irrigator, and aspirator system; Metal intramedullary nailing system; OPAL interbody fusion device.

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/b8ce95d6-78ae-4471-85b3-79393dc9ce6b
Source feed: China

> China NMPA product recall for Intramedullary nailing system; orthopedic surgical instruments - reamer, irrigator, and aspirator system; Metal intramedullary nailing system; OPAL interbody fusion device. by Synthes GmbH published February 29, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH is voluntarily recalling its intramedullary nail systems and metal intramedullary nail systems.
- Company Name: Synthes GmbH
- Publication Date: 2024-02-29
- Product Name: Intramedullary nailing system; orthopedic surgical instruments - reamer, irrigator, and aspirator system; Metal intramedullary nailing system; OPAL interbody fusion device.
- Recall Level: Level 3 Recall
- Recall Reason: Some batches of products had sterilization issues.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Synthes GmbH, a medical device manufacturer. This recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., was published on February 29, 2024. The central issue identified across the affected product batches pertains to sterilization deficiencies.

The recalled products encompass several critical medical device systems, including the Intramedullary Nailing System, RIA-Reamer Irrigator Aspirator, Metal Intramedullary Nailing System, and OPAL Interbody Fusion Device. Each of these products is authorized with specific National Medical Device Registration Certificates under the NMPA's stringent regulatory oversight. The Class III designation for this recall indicates a situation where there is a low probability that use of, or exposure to, a violative product will cause adverse health consequences.

Synthes GmbH commenced this voluntary recall to proactively address the identified sterilization problems. The precise models and specifications of the impacted batches are further detailed in an attached Medical Device Recall Event Report Form. This action emphasizes the manufacturer's commitment to upholding product quality and safety standards as mandated by NMPA regulations, aiming to mitigate any potential risks to patients associated with the identified issues.

Company: https://www.globalkeysolutions.net/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7