Spes Medica Via Buccari Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Brand
Spes Medica Via Buccari
Lot Codes / Batch Numbers
Lot SI20F2956I
Products Sold
Lot SI20F2956I
Spes Medica Via Buccari is recalling Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraopera due to The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Recommended Action
Per FDA guidance
An email titled "Object: Spes Medica Safety Notice for possible Non-Conformities to Steril Milano" dated 4/8/21 was sent to customers. Following the communications of Steril Milano and the Ministry of Health (http:ljwww.salute.gov.it/portale/news/p3 2 1 1 1.jsp ?lingua=italiano&menu=notizie&p=dalministero&id=5365) on possible deviations of the parameters/processes defined for ethylene oxide sterilization, already validated and routinely used by Steril Milano; the company Spes Medica S.r.I. informs you that in the years 2019-2020-2021 has used the Steril Milano supplier only once in- August 2020. However only for safety reason If you have the following products in your stock, we ask you to immediately block the sale and the use and, in case, to forward this request to your customers or sub-distributors. Please contact our Customer Service to send back to us the products, we will replace with another LOT number. For any request for clarification or support, do not hesitate to contact: Eng. Giorgio Facco e-mail: guality@spesmedica.com Telephone number: +39 010 80 667 67
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, MA, SC
Page updated: Jan 10, 2026