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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

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.
Recall Number Z-0924-2013
Classification Class II
Code Info Lot Number: 2385 Exp Date: 09/2013
Product Distributed Qty 22 units
Reason For Recall Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment

Event Detail

Event Id 64477
Product Type Devices
Status Terminated
Recalling Firm Keystone Dental Inc
City Burlington
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-05
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.