FDA-Device2018-04-04Class II
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,
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.
Sold states
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.
Affected count
83
Manufactured in
100 Discovery Way, Acton, MA, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2018Don't want to check this manually?
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