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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Straight Esthetic 4.0 mm 1mm Cuff Abutment		see related information
Date Posted March 08, 2013
Recall Number Z-0923-2013
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.
Code Information Lot Number: 2376 Exp Date: 09/2013
Recalling Firm/
Manufacturer		 Keystone Dental Inc
144 Middlesex Tpke
Burlington, Massachusetts 01803-4403
For Additional Information Contact SAME
781-328-3390
Reason for
Recall		 Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Action Keystone issued Market Withdrawal notice via fax on July 5, 2011, to affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the fax-back form to facilitate whether they hae any affected product and indicate whether they would like to receive a replacement of a full refund. Customers ewre asked to contact Keyston'es Customer Relations Department to coordinate shipment of the returned product. For questions regarding this recall call 781-328-3390.
Quantity in Commerce 35 units
Distribution Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
 
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