BioPro, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2245-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - 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

Product Classification:

Class II

Date Initiated: June 25, 2019

Date Posted: August 21, 2019

Recall Number: Z-2245-2019

Event ID: 83288

Reason for Recall:

Manufacturing flaw in the sterile barrier system

Status: Terminated

Product Quantity: 240 units

Code Information:

UDI - M209OL15025S0 Lot Number - 123219 MFG Date - 4/24/2019

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.

Voluntary or Mandated:

Voluntary: Firm initiated