Medicrea International: Medical Device Recall in 2026 - (Recall #: Z-1038-2026)

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 Universal Implant Inserter, Rx Only REF: A24000000

Product Classification:

Class II

Date Initiated: October 29, 2025

Date Posted: January 21, 2026

Recall Number: Z-1038-2026

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# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated