Class II — Potential Health Hazard

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

Orthex Large Bone Shoulder Bolt Recalled by OrthoPediatrics Corp Due to Bolt breakage on the head or threaded portion,...

Date: September 12, 2022
Company: OrthoPediatrics Corp
Status: Ongoing
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

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

Quantity: 1354 (594 US)

Why Was This 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.

Where Was This Sold?

Domestic distribution to Foreign distribution to

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