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Torosa

Coloplast A/S · Model 450-1327 · UDI-DI 05708932470834

FAF Prescription
0
510(k) clearances
153
Adverse events
1
Recalls
4
Facilities

Description

Saline Filled Testicular Prosthesis

Recalls

DateFirmReason
2010-04-30Coloplast Manufacturing US, LLCOn April 22, 2010, a decision was made by Coloplast to conduct a field correction based on a report that the Saline Filled Testicular Prosthesis is considered mislabeled. This is s

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Data 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.