Class II — Stryker Neurovascular
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. |
| Product | GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable. |
| Quantity | 316 total, both models |
| Distribution | Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine. |
| Initiated | 2016-03-21 |
| Classified | 2016-04-19 |
| Terminated | 2016-07-05 |
| Recall number | Z-1516-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stryker Neurovascular (Z-1516-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73705/
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