Medicrea International: Medical Device Recall in 2026 - (Recall #: Z-1039-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 29, 2025

Date Posted: January 21, 2026

Recall Number: Z-1039-2026

Event ID: 97996

Reason for Recall:

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

Status: Ongoing

Product Quantity: 44 units

Code Information:

Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174

Distribution Pattern:

US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

Voluntary or Mandated:

Voluntary: Firm initiated