Class II — Potential Health Hazard

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

Rival Reduce Kit Plates Recalled by Orthofix, Inc Due to Firm is conducting a voluntary recall of the...

Date: April 6, 2018
Company: Orthofix, Inc
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 Orthofix, Inc directly.

Affected Products

Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C

Quantity: 50

Why Was This Recalled?

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Where Was This Sold?

This product was distributed to 19 states: CA, FL, GA, IL, IN, LA, MD, MI, MN, NV, NJ, NC, OH, OK, PA, SC, TX, VA, DC

Affected (19 states)Not affected

About Orthofix, Inc

Orthofix, Inc has 30 total recalls tracked by RecallDetector.

Related Recalls

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