Spes Medica recalls Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological mo…

Recall date

April 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1971-2021

FDA classification

Class II

Brand / firm

Spes Medica

Sold / distributed

Distribution in the following US states: CA, MA, and SC.

Why it was recalled

The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.