# China NMPA Product Recall - Injector

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/dc3b1f67-b311-4f6f-b866-f0c4892c22d9/
Source feed: China

> China NMPA product recall for Injector by Synthes GmbH published May 20, 2015. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., collaborating with manufacturer Synthes GmbH

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls implantation devices.
- Company Name: Synthes GmbH
- Publication Date: 2015-05-20
- Product Name: Injector
- Recall Level: Level II
- Recall Reason: Complaints of certain inserters breaking inside the blade implant during insertion have exceeded expectations. If this occurs, it can affect the locking mechanism, consequently impacting rotational stability. This could lead to prolonged procedure time, bone damage, subsequent interventions, and even adverse tissue reactions.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., collaborating with manufacturer Synthes GmbH, initiated a Class II voluntary recall for a specific implant device model (03.224.007) on May 20, 2015, under the oversight of the National Medical Products Administration (NMPA). The recall was prompted by an elevated number of complaints regarding the device breaking inside the blade implant during surgical insertion. This critical issue can compromise the implant's rotational stability, which is crucial for successful implantation. If the broken fragments cannot be removed, it may necessitate replacement of the blade implant or the addition of traction screws, potentially leading to prolonged procedure times, bone damage, and subsequent interventions. Furthermore, there is a risk of adverse tissue reactions if fragments remain within the patient, despite the implant components being made of implantable-grade stainless steel. While two complaints were reported in China, no adverse events had occurred. The required corrective action involved instructing all affected distributors to immediately cease using the involved products and arrange for their return for either factory or local destruction, aiming to mitigate patient risk and address the product's functional deficiency.

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