# China NMPA Product Recall - Orthopedic reduction forceps

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/830942cd-0584-4148-8d25-734590b64100/
Source feed: China

> China NMPA product recall for Orthopedic reduction forceps by Synthes GmbH published December 10, 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 orthopedic reduction forceps
- Company Name: Synthes GmbH
- Publication Date: 2015-12-10
- Product Name: Orthopedic reduction forceps
- Recall Level: Level II
- Recall Reason: An investigation by the original manufacturer revealed that two batches of orthopedic reduction forceps were produced under substandard conditions. This could result in difficulties assembling the sleeve pusher onto the implant forceps, rendering the tool unusable as intended. This could lead to surgical delays and/or structural failure. To date, two complaints have been reported abroad regarding difficulties assembling the sleeve pusher onto the implant forceps, which would cause surgical delays of 10 to 30 minutes.
- 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 of specific batches of Orthopedic Reduction Forceps (Model 388.508) on December 10, 2015. This action was taken under the regulatory oversight of China's National Medical Products Administration (NMPA). The recall resulted from a manufacturer's investigation uncovering that two batches of the orthopedic reduction forceps were produced under non-standard conditions. This manufacturing defect can cause difficulty in assembling the sleeve push rod onto the implant forceps, potentially rendering the instrument unusable as intended. Such issues could lead to surgical delays, with two overseas complaints already reporting delays of 10 to 30 minutes, and possibly result in structural failure. The recall impacts several countries, including Germany, UK, Spain, India, China, South Africa, Brazil, and Mexico. For the Chinese market, six affected units were imported but designated solely as internal samples and were not distributed for sale. Therefore, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. concluded that no further on-site corrective actions are required within China to address this issue.

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