# China NMPA Product Recall - Locking bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/5151e103-2f42-460d-8330-a64a273d017f/
Source feed: China

> China NMPA product recall for Locking bone screws by Synthes GmbH published December 21, 2015. Recall level: . The National Medical Products Administration (NMPA) issued a recall notice on December 21, 2015, con

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls locking bone screws
- Company Name: Synthes GmbH
- Publication Date: 2015-12-21
- Product Name: Locking bone screws
- Recall Reason: The manufacturer has issued a field safety notice regarding potentially incorrect packaging instructions for a specific batch of affected products (GP2613, corresponding to the variable-angle locking screw). The correct packaging instructions should be for GP26150. Affected products have silver screw heads, while variable-angle locking screws have purple screw heads; this color difference should be easily noticeable to users. The technical guidelines provide system indications and surgical procedures, including the type of screw hole within the plate, the acceptable angle, and a description of the tools required for correct screw insertion. If users do not follow the technical guidelines and only refer to the incorrect packaging instructions, inserting the locking screw at a variable angle, the screw will not lock securely as expected due to the difference in screw and bone plate thread geometry. This may delay surgery due to the need to remove the screw and insert a replacement. If users do not follow the applicable technical guidelines and only refer to the incorrect packaging instructions, they may assume the product can be used in an unapproved manner. Improper use of the screw may damage the epiphyseal plate in adolescent patients with immature skeletal development, for example, causing malunion/nonunion.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a recall notice on December 21, 2015, concerning locking bone screws manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This voluntary recall, initially reported on November 15, 2015, addresses potentially incorrect packaging instructions for certain batches of variable angle locking screws (e.g., GP2613). The primary violation stems from instructions intended for a different product (GP26150) being included with the affected screws. This discrepancy poses a risk that users might not follow the correct technical guidelines, leading to variable-angle screws failing to lock securely, which could cause surgical delays. More critically, improper use might damage the epiphyseal plate in adolescent patients, potentially resulting in conditions such as malunion or nonunion. While there is a noticeable color difference between the screw types, the incorrect instructions present a significant safety concern. This recall, operating under the NMPA's regulatory framework (formerly CFDA), primarily affects products sold in the USA and Canada. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that the recalled products were not imported into China. Consequently, no direct corrective actions are required for products within China. However, Chinese provincial food and drug administrations are directed to strengthen their oversight and management of similar medical devices.

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