# China NMPA Product Recall - Trauma Surgical Instrument Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/753cbc01-e861-4551-8385-d269c529a8e6/
Source feed: China

> China NMPA product recall for Trauma Surgical Instrument Kit by Synthes GmbH published January 13, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a recall notification regarding trauma su

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls trauma surgery instrument kits
- Company Name: Synthes GmbH
- Publication Date: 2016-01-13
- Product Name: Trauma Surgical Instrument Kit
- Recall Reason: The affected medullary canal enlargement drill should have been 14mm in diameter, but was incorrectly etched to 13.5mm. This could result in the surgeon widening the canal by 1.0mm instead of 0.5mm at a time, posing a risk of the drill getting stuck, potentially delaying surgery or causing bone damage.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: The National Medical Products Administration (NMPA) issued a recall notification regarding trauma surgical instrument kits manufactured by Synthes GmbH. This voluntary recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on December 15, 2015, and published on January 13, 2016, addresses a significant etching error. Medullary canal reamers, essential tools for fracture fixation, were incorrectly marked as 13.5mm in diameter when their actual size was 14mm. This mislabeling poses a risk that surgeons could inadvertently widen the medullary canal by 1.0mm instead of the intended 0.5mm increment. Such an error could lead to the drill becoming stuck, potentially causing surgical delays, necessitating reamer removal, or even resulting in bone damage. While Synthes GmbH initiated the recall under the NMPA's regulatory framework, Johnson & Johnson (Shanghai) confirmed that no affected product batches were sold or imported into China. Therefore, no direct on-site corrective actions are required within the country. The NMPA has advised provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management of similar medical devices to safeguard patient safety.

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