OrthoPediatrics Corp recalls OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an…

Recall date

August 19, 2019

Source

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

Recall number

Z-0125-2020

FDA classification

Class II

Brand / firm

OrthoPediatrics Corp

Sold / distributed

Nationwide Foreign: Australia

Why it was recalled

Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

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

What was recalled

OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032