Class II — Potential Health Hazard

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

Medicrea Recalled by Medicrea International Due to Due to complaints, orthopedic rotation tool handle may...

Date: October 29, 2025
Company: Medicrea International
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 Medicrea International directly.

Affected Products

Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

Quantity: 44 units

Why Was This Recalled?

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medicrea International

Medicrea International has 22 total recalls tracked by RecallDetector.

Related Recalls

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