Class II — Potential Health Hazard

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

OrthoPediatrics ACL Reconstruction System is a pediatric and small stature Recalled by OrthoPediatrics Corp Due to Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool,...

Date: November 7, 2013
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

OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

Quantity: 40

Why Was This Recalled?

Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.

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