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Recall Observatory FDA recall evidence

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

July 05, 2011

Class II

Product summary

Firm
Keystone Dental Inc
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

    reason.labeling_packaging · v1.0.0

    Mislabeled