FDA recall Z-1039-2026

Medicrea International · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-10-29
Report date
2026-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rillieux La Pape, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2026