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BIONESS
XAVANT TECHNOLOGY (PTY) LTD · Model STIMPOD ST2-3000 KIT · UDI-DI 06009880396184
BXN
Prescription
1
510(k) clearances
31
Adverse events
5
Recalls
19
Facilities
Description
The STIMPOD ST2-3000 is a nerve stimulation device designed to be used for the purpose of nerve locating using percutaneous electrodes or needles (not supplied).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2010-02-01 | Stryker Instruments Div. of Stryker Corporation | Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.