Recall Z-1904-2020

Reason for recall

The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.

FDA-determined cause: Nonconforming Material/Component

Action taken

The firm notified their US sales managers via teleconference on 07/19/2019. The sales managers coordinated distribution of the notification letter to the distributors and surgeons. All 12 US surgeons received both in-person verbal and written notices (hand delivered by sales reps) subsequent to the 07/19/2019 teleconference meeting. Recall actions for products sold in Japan were coordinated by the firm's parent company. In the firm's "Urgent Advisory Notice/Medical Device Recall Notice", dated 07/16/2019 includes the following instructions for end users: Contacting affected patients should be at the discretion of the surgeon to discuss the risks identified. The surgeon should weigh the risk of removing an implanted device against the risk of leaving it in place. Absence of clinical failure should be considered during the decision-making process. The appropriate action is left to the judgment of the surgeon and the preference of the patient. Complete and return the Customer Acknowledgement form. For any questions or concerns, call 801-553-9991 or contact via email at Ryan_Carpenter@orthodevelopment.com.