XTANT Medical Holdings, Inc: Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

Hazard

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

Details from the source

Reason for recall: Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging. Distribution: US distribution in MI. Quantity: 6 Lot/code info: UDI-DI: 00810076564005, Lot: AP23000143

UPC codes

00810076564005

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.