FDASeptember 10, 2019device
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or to...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
What to do
FDA enforcement status: Terminated
Brands named
medtech sasmedtech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning ...2024-08-05
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- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST1752024-01-26
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