Comprehensive Reverse Shoulder System Humeral Tray Model 115340

Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

On 12/20/2016, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 2/1/2017, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Surgeons, Risk Managers, and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The 2/1/2017 notice identified additional product lots that had been added to the affected product list, as well as included patient monitoring guidance for surgeons.