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Genesis
Coloplast A/S · Model 91-9513SC · UDI-DI 05708932324809
FAE
Prescription
1
510(k) clearances
2,754
Adverse events (1 deaths)
3
Recalls
10
Facilities
Description
Malleable Penile Prosthesis
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-09 | Coloplast Manufacturing US, LLC | Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is print |
| 2007-02-19 | American Medical Systems | Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
| 2007-02-19 | American Medical Systems | Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
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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.