Spes Medica: Medical Device Recall in 2021 - (Recall #: Z-1971-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 8, 2021

Date Posted: July 7, 2021

Recall Number: Z-1971-2021

Event ID: 87999

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 boxes

Code Information:

Lot SI20F2956I

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated