Ortho Solutions product recalled over labeling errors

Recall date

April 19, 2017

Source

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

Official notice title

Ortho Solutions Inc recalls Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft t…

Recall number

Z-2780-2017

FDA classification

Class II

Brand / firm

Ortho Solutions Inc

Sold / distributed

US distribution to MD, NY & PA

Why it was recalled

There is a material mislabeling of the AFN End Cap.

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

What was recalled

Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.