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U.S. Department of Health and Human Services

Class 2 Device Recall Straight Esthetic 4.0 mm 1mm Cuff Abutment

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 Class 2 Recall
Straight Esthetic 4.0 mm 1mm Cuff Abutment
see related information
Date Posted March 08, 2013
Recall Status1 Terminated on March 11, 2013
Recall Number Z-0923-2013
Recall Event ID 64477
Premarket Notification
510(K) Number
K101545 
Product Classification Abutment, Implant, Dental, Endosseous - Product Code NHA
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
Manufacturer Reason
for Recall
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = KEYSTONE DENTAL
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