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TACTRA
BOSTON SCIENTIFIC CORPORATION · Model 720081-01 · UDI-DI 08714729979357
FAE
Prescription
10
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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