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U.S. Department of Health and Human Services

Class 2 Device Recall Penile Prosthesis

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  Class 2 Device Recall Penile Prosthesis see related information
Date Initiated by Firm July 17, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on May 01, 2012
Recall Number Z-2461-2008
Recall Event ID 49376
Product Classification Penile inflatable implant. - Product Code JCW
Product AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20.
Code Information Lot # 551668
Recalling Firm/
Manufacturer		 American Medical Systems
10700 Bren Rd W
Minnetonka MN 55343-9679
For Additional Information Contact
952-930-6541
Manufacturer Reason
for Recall		 The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump.
FDA Determined
Cause 2		 Employee error
Action On July 17, 2008, the physician who implanted the device received a phone call from AMS to discuss the event and be sure he understands what went wrong (Ultrex cylinders implanted instead of CX) and any new risks introduced to his patient so he can properly assess any impact it may have. A follow up letter " AMS Important Product Recall" dated July 21, 2008 was also sent to document the event and the call. The letter requested to return of the "Recall Acknowledgement Form". The second physician (tried not used) has already returned the device and will not receive further communication. A complaint was assigned to document the event.
Quantity in Commerce 5 units
Distribution LA
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.
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