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

Hazard

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

Details from the source

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. Quantity: 44 units Lot/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

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.