# China NMPA Product Recall - Trauma surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/d90c6d1a-a6de-4093-898c-781045bf67a2/
Source feed: China

> China NMPA product recall for Trauma surgical instruments by Synthes GmbH published July 24, 2015. Recall level: Level II. The National Medical Products Administration (NMPA) announced a Class II voluntary recall by Johnson

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls trauma surgery instruments.
- Company Name: Synthes GmbH
- Publication Date: 2015-07-24
- Product Name: Trauma surgical instruments
- Recall Level: Level II
- Recall Reason: The manufacturer discovered that the affected products were manufactured according to incorrect hardness specifications, which could lead to intraoperative breakage. Surgeons would need to perform foreign body removal procedures, including using X-rays to determine the location and size of fragments, potentially prolonging the operation. Fragments that are difficult to remove may require additional incisions and could cause soft tissue damage. The presence of non-implantable materials in the broken instrument fragments may cause patient allergies, and fragments remaining in the bone may trigger inflammatory reactions, leading to adverse tissue damage. The company has received related complaints and reports of adverse events.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., concerning trauma surgical instruments manufactured by Synthes GmbH. This recall, reported on July 17, 2015, addresses a critical manufacturing defect: the affected instruments, specifically Model 03.120.023, were produced with incorrect hardness specifications. This manufacturing error creates a significant risk of instrument breakage during surgical procedures. Potential patient safety issues include prolonged operation times, the necessity for foreign body removal procedures (potentially requiring additional incisions and causing soft tissue damage), allergic reactions due to non-implantable material fragments, and inflammatory responses if fragments remain in bone. Despite these risks, no related complaints or adverse events had been reported in China at the time of the recall. Regulatory actions mandated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. require affected distributors to immediately cease using the compromised products and to either return them to the manufacturer or ensure their local destruction. This measure aims to prevent further use of the defective instruments, impacting specific batch numbers globally, including two consignments imported into China.

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