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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 08, 2021
Create Date June 25, 2021
Recall Status1 Terminated 3 on May 10, 2022
Recall Number Z-1971-2021
Recall Event ID 87999
510(K)Number K133348  
Product Classification Stimulator, nerve - Product Code ETN
Product Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Code Information Lot SI20F2956I
Recalling Firm/
Manufacturer		 Spes Medica
Via Buccari 21
Genoa Italy
Manufacturer Reason
for Recall		 The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
FDA Determined
Cause 2		 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 in Commerce 3 boxes
Distribution Distribution in the following US states: CA, MA, and SC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ETN and Original Applicant = SPES MEDICA S.R.L.
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