Class II — Potential Health Hazard

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

Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Recalled by CarboFix Orthopedics, Ltd. Due to Firm received complaints where the Piccolo Composite Ball...

Date: May 10, 2016
Company: CarboFix Orthopedics, Ltd.
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 CarboFix Orthopedics, Ltd. directly.

Affected Products

Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

Quantity: 638

Why Was This Recalled?

Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

Where Was This Sold?

This product was distributed to 19 states: AL, AZ, CA, CO, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA, DC

Affected (19 states)Not affected

About CarboFix Orthopedics, Ltd.

CarboFix Orthopedics, Ltd. has 1 total recall tracked by RecallDetector.

Related Recalls

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