FDAFDA · Food and drugs·Recall number Z-0923-2013
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Published March 20, 2013 · Recall initiated: July 5, 2011
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
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Keystone Dental Inc
- Distributor
- Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
- Lot
- Lot Number: 2376 Exp Date: 09/2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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