Z-1971-2021Class II

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

Name: Z-1971-2021 Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative...
Creator: Spes Medica
Published: 2021-04-08
License: https://open.fda.gov/license/

Spes Medica S.P.A / initiated 2021-04-08 / Terminated / root cause: manufacturing process

FDA source

Spes Medica began a recall of Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring on 2021-04-08. FDA classified it as Class II and gives the reason as "The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1971-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-08
Posted: 2021-06-25
Terminated: 2022-05-10
Recalling firm: Spes Medica S.P.A
Product: Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Product code: ETN Stimulator, Nerve
Reason for recall: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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: [email protected] Telephone number: +39 010 80 667 67
Quantity in commerce: 3 boxes
Distribution: Distribution in the following US states: CA, MA, and SC.
Product codes and lots: Lot SI20F2956I

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1971-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1967-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1968-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1969-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1970-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1971-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25

Product code ETN

K133348Class IIStim ProbeSpes Medica Srl / cleared 2014-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)