The Recall Desk

FDA (Devices) recall action 73705

Stryker Neurovascular recalled 2 products on 2016-04-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-04-27
Critical
0
Units
632

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-04-27

    Stryker GDC 360 Detachable Coils Recalled for Incorrect DFU Packaging

    Stryker Neurovascular is recalling GDC 360 Detachable Coils because an incorrect Device Form Unique (DFU) was packaged with two lots.

    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 conditio
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2016-04-27

    Stryker GDC 360 Detachable Coils Recalled for Incorrect Device Formulation

    Stryker Neurovascular is recalling 316 GDC 360 Detachable Coils because an incorrect Device Formulation Unit (DFU) was packaged with the product.

    Product
    GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical conditio
    Category
    Distribution
    7 states