FDA recall Z-1262-2018

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,

Reason for recall

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.

Distribution

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.

Key facts

Status

Terminated

Initiation date

2018-02-21

Report date

2018-04-04

Termination date

2020-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Acton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2018