# China NMPA Product Recall - Spring coil (product name: GDC 360)

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-neurovascular/3b48ef91-8cdf-424b-acfe-d11e58ee247d/
Source feed: China

> China NMPA product recall for Spring coil (product name: GDC 360) by Stryker Neurovascular published April 13, 2016. Recall level: . The National Medical Products Administration (NMPA) announced a recall initiated by Stryker Neurovas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Neurovascular is recalling its coils (brand name: GDC 360).
- Company Name: Stryker Neurovascular
- Publication Date: 2016-04-13
- Product Name: Spring coil (product name: GDC 360)
- Recall Reason: The manufacturer discovered that the instruction manuals for the affected batches were incorrect and had to be replaced with manuals for a similar model. Although the differences between the two manuals are minor, this issue could still potentially prolong the surgical procedure.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Neurovascular
- Summary: The National Medical Products Administration (NMPA) announced a recall initiated by Stryker Neurovascular concerning their GDC360 coils, as reported by Stryker (Beijing) Medical Devices Co., Ltd. The primary issue involved errors in the product instructions for specific manufacturing batches (e.g., 17074659, 17159739), where the correct instructions were mistakenly replaced with those for a similar device model. While the differences were deemed minor, this discrepancy posed a potential risk of prolonging surgical procedures. These GDC360 coils, registered under CFDA (Imported) No. 20143773644, are utilized for embolizing intracranial aneurysms and other neurovascular malformations. The voluntary recall impacted several global regions, including Hong Kong, the USA, and various European countries. Crucially, the affected product batches were not distributed or sold within mainland China. Therefore, Stryker (Beijing) communicated to the NMPA that no further corrective actions were required domestically, beyond the initial report submitted on March 21, 2016. In response, the NMPA directed regional food and drug administrations to intensify oversight of similar medical devices.

Company: https://www.globalkeysolutions.net/companies/stryker-neurovascular/dfa4048f-7c78-4970-ab1b-8a34319b33ba/