Z-1038-2026Class II

Medicrea International

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-01-21

Distribution

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

Product quantity

44 units

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →