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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 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.
Recall Number Z-0923-2013
Classification Class II
Code Info Lot Number: 2376 Exp Date: 09/2013
Product Distributed Qty 35 units
Reason For Recall Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm 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.