| Class 2 Device Recall Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment |  |
Date Initiated by Firm | July 05, 2011 |
Date Posted | March 08, 2013 |
Recall Status1 |
Terminated 3 on March 11, 2013 |
Recall Number | Z-0924-2013 |
Recall Event ID |
64477 |
510(K)Number | K101545 |
Product Classification |
Genesis Abutment, implant, dental, endosseous - Product Code NHA
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Product | 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. |
Code Information |
Lot Number: 2385 Exp Date: 09/2013 |
Recalling Firm/ Manufacturer |
Keystone Dental Inc 144 Middlesex Tpke Burlington MA 01803-4403
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For Additional Information Contact | SAME 781-328-3390 |
Manufacturer Reason for Recall | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment |
FDA Determined Cause 2 | Mixed-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 | 22 units |
Distribution | Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NHA
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