Device product
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.
Z-0923-2013
Product summary
- Event
- Event 64477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-0923-2013
Official wording
Reason: Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Code information: Lot Number: 2376 Exp Date: 09/2013
Distribution pattern: Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
Derived failure modes
-
Labeling or packaging
Mislabeled