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SINUREP
MEDAX SRL UNIPERSONALE · Model SR20080-03 · UDI-DI 08055002909556
MIJ
Prescription
0
510(k) clearances
119
Adverse events (1 deaths)
3
Recalls
23
Facilities
Description
Breast localization needle 20G x 80 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-03 | Somatex Medical Technologies GMBH | This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments |
| 2016-01-08 | Cook Inc. | Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. |
| 2003-09-04 | Alpha-Omega Services Inc | Template needle may fracture leaving tip in patient. |
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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.