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Terminated

Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.

FDA Recall Z-0171-2010 · Posted 2009-11-10

Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeFHW
Date Initiated2009-10-06
Date Terminated2011-12-12
Product Quantity3

Reason for Recall

Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the prod

Firm Action

Coloplast issued a customer notification letter dated October 2009 describing the affected product. For further information, contact Coloplast at 1-800-533-0464.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- FL, GA, NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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