LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.

The firm initially contacted their customers by phone between 11/20-22/2019 and then sent out Customer Notification Letters on 11/22/2019 via email. The Customer Notification Letter is informing customers: The firm has determined that the abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient. The potential gap between the implant and the abutment could result in a space for bacteria to potentially harbor and grow, which could lead to an increase in future infection risk. To mitigate this risk, the abutment should be replaced without removing the implant. If this action is taken, the abutment z-position may be lowered, and the denture as originally "picked-up" may result in a sub-optimal denture fit (i.e., exerting additional force on the tissue). In this situation, the clinician/patient will need to re-evaluate the denture fit. If needed, the denture may be re-aligned per standard practice to return the denture to optimal fit. Customer are requested to: -Separate and quarantine any of the affected products that are currently in their inventory and return them to the Recalling Firm. -Complete, sign and return the Acknowledgement & Receipt Forms and email to [email protected]. -Ask the healthcare professionals (end users) to return products. In additional, customer are being informed: -If the implant and abutment have not been used: 1. Separate and quarantine any of the affected product that are currently in their inventory. 2. If the product has been further distributed, notify customers and retrieve, as appropriate. 3. Return affected product for a free of charge replacement. -If the implant has been placed, contact the Recalling Firm at 800-262-2310 for recommended actions and replacement product dependent upon the following circumstance: 1. Implant has been placed, but not restored: The Recalling Firm do