Device product
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Z-1971-2021
Product summary
- Firm
- Spes Medica
- Event
- Event 87999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 boxes
- Official record key
device-enforcement:Z-1971-2021
Official wording
Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Code information: Lot SI20F2956I
Distribution pattern: Distribution in the following US states: CA, MA, and SC.
Derived failure modes
-
Unknown
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.