Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for ...
FDA Recall #Z-0924-2013 — Class II — July 5, 2011
Product Description
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Reason for Recall
Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
Recalling Firm
Keystone Dental Inc — Burlington, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22 units
Distribution
Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
Code Information
Lot Number: 2385 Exp Date: 09/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated