Mac Pin Non-Cannulated Screw recalled over labeling errors

Recall date

July 7, 2017

Source

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

Official notice title

Amendia, Inc recalls Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Recall number

Z-0325-2018

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

Distribution to Georgia, USA.

Why it was recalled

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

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

What was recalled

Mac Pin Non-Cannulated Screw, 6.5 x 60mm