Z-1971-2021 Class II Terminated
FDA device recall Z-1971-2021 was initiated by Spes Medica on April 8, 2021 and is designated Class II. Reason for recall: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. The recall status is terminated (terminated May 10, 2022). Affected quantity: 3 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- April 8, 2021
- Termination Date
- May 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 boxes
Product Description
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 Pattern
Distribution in the following US states: CA, MA, and SC.
Code Information
Lot SI20F2956I