FDAFDA · Food and drugs·Recall number Z-2125-2017
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Published May 31, 2017 · Recall initiated: May 2, 2017
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
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
- Lot
- 89103, 83493, 78986
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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