Implant Direct HHE-6050-52-60Rev01 - Replant 5.0mmD Abutment Assy 15 deg Angled

Through our internal Regulatory Affairs evaluation (Health Hazard Evaluation) process, we have found a possible issue with the design specification, manufactured outside of specifications. Specifically, some consignees received product that may have been out of specifications set by the company. Our current data indicates the possibility of this occurring is remote (<0.10%). In the event the consignee has this product in their inventory, the product will not fit into the implant as indicated. This discrepancy may lead to the screw loosening and the patient would need to return to the Doctor for an additional non-surgical procedure. In worst case scenario crown could come loose and patient could swallow it. This would not cause a long term health consequence. Our current data indicates the possibility of this occurring is remote (<0.1%). If the product has been used with no issues no further action is necessary.