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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 18 Results
PMA Number: P000006
 
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Product Description
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FDA Recall
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Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N Q... 2 11/10/2009 Coloplast Manufacturing US, LLC
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis 2 04/12/2023 Coloplast Manufacturing US, LLC
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