Class II — Potential Health Hazard

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

K-Wire Sterile Single Trochar .045 Recalled by BioPro, Inc. Due to Manufacturing flaw in the sterile barrier system

Date: June 25, 2019
Company: BioPro, 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 BioPro, Inc. directly.

Affected Products

K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

Quantity: 1 unit

Why Was This Recalled?

Manufacturing flaw in the sterile barrier system

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BioPro, Inc.

BioPro, Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

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