# China NMPA Product Recall - craniofacial bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/d1152e0a-64a8-4f27-9a2e-ead60b693ff8/
Source feed: China

> China NMPA product recall for craniofacial bone screws by Synthes GmbH published April 13, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls craniofacial bone screws.
- Company Name: Synthes GmbH
- Publication Date: 2016-04-13
- Product Name: craniofacial bone screws
- Recall Reason: The manufacturer discovered that the affected screws had a thread height below standard. Insufficient thread height may affect self-drilling function, making screw insertion difficult. Even if the screw can be inserted, insufficient thread height will significantly reduce the screw's holding force within the bone, thus affecting screw fixation stability, potentially leading to instrument loosening, or even malunion/nonunion.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall initiated by Synthes GmbH for specific craniofacial bone screws (models 400.833 and 400.833.04C). This recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on March 8, 2016, and published by the NMPA on April 13, 2016, addresses a critical quality issue. The manufacturer identified that the affected screws had a lower-than-standard thread height. This defect could impair the screw's self-drilling function, hinder insertion, and significantly reduce its holding force within bone, potentially leading to fixation instability, instrument loosening, or surgical complications like malunion or nonunion.

While the recall impacts several international regions, it is significant that no units of the affected products were imported into or sold within China, thus mitigating direct patient risk in the country. In light of this manufacturing concern, the NMPA has requested that provincial, autonomous region, and municipal food and drug administrations enhance their oversight and management of similar medical devices. This action underscores the NMPA's commitment to patient safety and adherence to regulatory frameworks for medical device reporting, even when products have not entered the domestic market.

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