FDA Medical Device Recalls (openFDA)
Spes Medica: Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
- Recall number
- Z-1971-2021
- Recalling firm
- Spes Medica
- Product
- Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
- Status
- Terminated
- Initiated
- 2021-04-08
- Posted
- not on file
- Terminated
- 2022-05-10
- Reason
- The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- 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: guality@spesmedica.com Telephone number: +39 010 80 667 67
- Quantity
- 3 boxes
- Distribution
- Distribution in the following US states: CA, MA, and SC.
- Lot, serial or model codes
- Lot SI20F2956I
- 510(k) numbers
- ["K133348"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 3011534533
- Firm city
- Genoa
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28