Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1516-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-03-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1516-2016
Date of alert: 2016-03-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Neurovascular
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 17074659

Reported risk: The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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