medical Class II Updated 2024-02-07

XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fi

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: MI
Lot/Code Info: UDI-DI: 00810076564005, Lot: AP23000143
View official government recall

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