Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Recalled by OrthoPediatrics Corp Due to Binding can occur between the attachment bolt and...

Date: August 19, 2019
Company: OrthoPediatrics Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OrthoPediatrics Corp directly.

Affected Products

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.

Quantity: 969 total

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OrthoPediatrics Corp

OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report