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U.S. Department of Health and Human Services

Class 2 Device Recall Titan OTR Inflatable Penile Prosthesis

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 Class 2 Recall
Titan OTR Inflatable Penile Prosthesis
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on December 12, 2011
Recall Number Z-0171-2010
Recall Event ID 53531
Premarket Approval
PMA Number
P000006
Product Classification Device, Impotence, Mechanical/Hydraulic - Product Code FHW
Product 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.
Code Information Lot 1919244.
Recalling Firm/
Manufacturer
Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis, Minnesota 55411-3430
Manufacturer 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
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Coloplast issued a customer notification letter dated October 2009 describing the affected product. For further information, contact Coloplast at 1-800-533-0464.
Quantity in Commerce 3
Distribution Nationwide Distribution -- FL, GA, NC.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = FHW and Applicant = COLOPLAST A/S
PMAs with Product Code = FHW and Applicant = COLOPLAST CORP.
PMAs with Product Code = FHW and Applicant = COLOPLAST MANUFACTURING US, LLC
PMAs with Product Code = FHW and Applicant = MENTOR CORP.
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