Recall Z-0924-2013 ยท NHA Abutment, Implant, Dental, Endosseous
Keystone Dental Inc
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.
| Date | Mar 8, 2013 (initiated Jul 5, 2011) |
| Status | Terminated |
| Reason | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment |
| Root cause | 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 | 22 units |
| Distribution | Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101545 | GENESIS IMPLANT SYSTEM Keystone Dental, Oct 28, 2010 |