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Allen Medical Systems recalls F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positi
Recalled April 4, 2018 · FDA recall Z-1262-2018 · Allen Medical Systems
Hazard
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient. · FDA Class II
Units
83
Sold at
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.
Description
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Product
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
Manufacturer(s)
Allen Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →