FDA recall Z-1971-2021

Spes Medica · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-04-08
Report date
2021-07-07
Termination date
2022-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Genoa, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1971-2021