# China NMPA Product Recall - Trauma Surgical Instrument Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/6ec2a355-19b5-43d5-a8d7-ea94f0dabd03
Source feed: China

> China NMPA product recall for Trauma Surgical Instrument Kit by Synthes GmbH published December 10, 2015. Recall level: . Synthes GmbH initiated a voluntary recall of specific batches of its Trauma Surgical Instrument Kits

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls trauma surgery instrument kits
- Company Name: Synthes GmbH
- Publication Date: 2015-12-10
- Product Name: Trauma Surgical Instrument Kit
- Recall Reason: The manufacturer's evaluation revealed that certain batches of femoral neck screw implanters may have been etched with incorrect screw lateral bevel orientation patterns, potentially causing a mismatch between the screw tip and the tool's angle. If discovered during surgery, this could lead to delays. Additional X-ray imaging may be required while the surgeon identifies and positions the screw correctly before locking it in the intramedullary nail. If the surgeon uses an incorrectly oriented femoral neck screw implanter as a reference for the bevel orientation and fails to detect the problem during implantation, soft tissue injury may occur because the beveled surface of the screw's lateral end is not aligned with the lateral cortex as intended.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH initiated a voluntary recall of specific batches of its Trauma Surgical Instrument Kits due to a manufacturing defect involving a possible incorrect angular orientation pattern etched on the femoral neck screw implanter. This specialized auxiliary surgical tool defect could lead to a mismatch between the screw tip and the tool angle. Potential issues include surgical delays if the problem is identified during an operation, possibly requiring additional X-ray imaging. More critically, if the incorrect orientation is used as a reference during implantation and goes undetected, it could result in soft tissue injury due to the screw's beveled section not aligning as intended by the surgeon.The recall report was published by the National Medical Products Administration (NMPA) on December 10, 2015, based on information provided by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on November 5, 2015, which distributes Synthes products in China. Under the regulatory framework, provincial and municipal food and drug administrations are requested to strengthen oversight of such products. However, the report explicitly states that none of the affected products were sold or imported into China. Consequently, beyond the initial reporting to the State Food and Drug Administration, no further actions, investigations, or reports are required from Johnson & Johnson or the NMPA in China concerning this recall. The recall primarily impacts regions outside China, including Austria, France, Germany, and the UK.

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