OrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17

Recall date

September 12, 2022

Source

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

Recall number

Z-0277-2023

FDA classification

Class II

Brand / firm

OrthoPediatrics Corp

Sold / distributed

Domestic distribution to Foreign distribution to

Why it was recalled

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

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

What was recalled

Orthex Large Bone Shoulder Bolt, model no. AS-17