XTANT Medical recalls Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

Recall date

May 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2500-2020

FDA classification

Class II

Brand / firm

XTANT Medical

Sold / distributed

AZ, TX and WV.

Why it was recalled

The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591