Recall Z-1279-2013
American Medical Systems, Inc. · initiated March 1, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
Codes / lots: Model # Lot # 720172-01 737875001 720172-01 737875002 720172-01 737875003 720172-01 737875004 72400098 714613001 72400098 714613002 72400098 714613003 72400098 714613004 72400098 714613005 72400098 714613006 72400098 714613007 72400098 714613008 72400098 714613009 72400098 714613010 72400098 714613011 72400098 714613013 72400098 714613014 72400098 714613015 72400098 714631001 72400098 714631002 72400098 714631003 72400098 714631004 72400098 714631005 72400098 714631006 72400098 714631007 72400098 714631008 72400098 714631009 72400098 714631010 72404127 786981017 72400098 714631014 72400098 714631015 72400098 714631016 72400098 714631017 72400098 714631018 72400098 714631019 72400098 714631020 72400098 714644001 72400098 714644002 72400098 714644003 72400098 714644004 72400098 714644005 72400098 714644007 72400098 714644008 72400098 714644009 72400098 714644010 72400098 714644011 72400098 714644012 72400098 714644013 72400098 714644014 72400098 714644015 72400098 714644016 72400098 714644017 72400098 714660001 72400098 714660002 72400098 714660003 72400098 714660004 72400098 714660005 72400098 714660007 72400098 714660008 72400098 714660010 72400098 714660012 72400098 714660013…
Reason for recall
American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
FDA-determined cause: Release of Material/Component prior to receiving test results
Action taken
American Medical Systems sent two written communications distributed within the United States. The first is a letter that is being delivered to customers who purchased the affected lots using their ship to address from the original sales order. The second is a letter being delivered to implanting physician customers who are known by AMS to be regular users of the devices. Similar letters will be sent to international customers, including both end users and distributors (where applicable). American Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letters identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to return the recalled product and to complete the Product Recall Acknowledgement Form. The letters addressed to "Physicians" advised consignees against prophylactic removal of implanted control pumps and pressure-regulating balloons contained within the scope of the product recall. For further questions please call AMS Customer Service at 1 (800) 328-3881
Details
- Recall number
- Z-1279-2013
- Initiated
- March 1, 2013
- Posted by FDA
- May 10, 2013
- Terminated
- April 24, 2014
- Product code
- EZY – Device, Incontinence, Mechanical/Hydraulic
- Quantity
- 605
- Distribution
- Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT…
- Recalling firm
- American Medical Systems, Inc., Minnetonka, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1280-2013 Class II | AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat…American Medical Systems, Inc. is initiating a recall on two components of the AMS 800 Urinary Control… | 03/01/2013Terminated |