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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = FHW
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