FDAFDA · Food and drugs·Recall number Z-1976-2013
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Published August 28, 2013 · Recall initiated: May 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- Nationwide Distribution.
- Lot
- K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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