Class IIReported 2026-01-21

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

Reason for Recall

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

Recall Number

Z-1039-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-10-29

Reported

2026-01-21

Distribution

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

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.