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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 Device Recall Titan OTR Inflatable Penile Prosthesis see related information
Date Initiated by Firm October 06, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on December 12, 2011
Recall Number Z-0171-2010
Recall Event ID 53531
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 MN 55411-3430
For Additional Information Contact
612-302-4992
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		 Process control
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = FHW and Original Applicant = COLOPLAST CORP.
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