OrthoPediatrics Corp recalls Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: a…

Recall date

August 19, 2019

Source

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

Recall number

Z-0219-2020

FDA classification

Class II

Brand / firm

OrthoPediatrics Corp

Sold / distributed

Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.

Why it was recalled

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays 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

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.