# China NMPA Product Recall - Multiaxial pedicle screw fixation system (trade name: SYNTHES) - Spinal surgical implant - Thoracolumbar fixation system - Spinal pedicle screw fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/14bb4e97-5b00-463f-acb5-f4eb7a6bc8a5/
Source feed: China

> China NMPA product recall for Multiaxial pedicle screw fixation system (trade name: SYNTHES) - Spinal surgical implant - Thoracolumbar fixation system - Spinal pedicle screw fixation system by Synthes GmbH published December 09, 2015. Recall level: Class I Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level I recall for spec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its Multiaxial Pedicle Screw Fixation System (trade name: SYNTHES) spinal surgical implant - Thoracolumbar fixation system.
- Company Name: Synthes GmbH
- Publication Date: 2015-12-09
- Product Name: Multiaxial pedicle screw fixation system (trade name: SYNTHES) - Spinal surgical implant - Thoracolumbar fixation system - Spinal pedicle screw fixation system
- Recall Level: Class I Recall
- Recall Reason: The manufacturer has identified five batches of affected products that may have been manufactured using sandblasting balls with a head length shorter than specified. Sandblasting the screw head prevents postoperative movement or slippage of the universal screw head within the assembled internal fixation structure. Reduced sandblasting area may decrease screw head friction, thus reducing its performance against universal screw movement/slippage. To date, the manufacturer has not received any complaints regarding universal screw/reset screw movement or slippage due to reduced sandblasting area. For patients with implanted affected USS/URS screws, prophylactic removal is not recommended; patients should be monitored according to standard USS/URS treatment practice guidelines. No related complaints or adverse events have been reported in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level I recall for specific batches of its Multiaxial Pedicle Screw Fixation System (SYNTHES) spinal surgical implants. The recall, reported on January 11, 2015, and published by the National Medical Products Administration (NMPA) on December 9, 2015, stemmed from the manufacturer, Synthes GmbH, discovering a manufacturing deviation. The issue involved five batches of products potentially produced with sandblasted balls having a shorter head length than specified. This reduced sandblasting area could decrease screw head friction, potentially affecting the resistance to movement or slippage of the universal screw within the internal fixation structure. The affected products, designed for posterior internal fixation of the thoracic, lumbar, and sacral spine, were imported to and sold in China, among other regions. To date, no complaints or adverse events related to this specific issue have been reported globally or in China. The required actions include notifying affected customers to cease using and return the impacted products for either manufacturer return or local destruction. Prophylactic removal of implanted screws is not recommended for patients; instead, standard monitoring guidelines should be followed.

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