Class 2 Device Recall SmartPump Tourniquet Stystem

• Date Initiated by Firm: April 13, 2010
• Date Posted: January 18, 2011
• Recall Status: Terminated on May 16, 2011
• Recall Number: Z-0915-2011
• Recall Event ID: 56624
• 510(K)Number: K032601
• Product Classification: Generator, lesion, radiofrequency - Product Code GXD
• Product: Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210.; The product is intended for coagulation of soft tissues in orthopedic, spinal and neuorsurgical applications.
• Code Information: LES5235, LES5236, LES5237, LES5238, LES5239, LES5240, LES5241, LES5242, LES5243, LES5244, LES5245, LES5246, LES5247, LES5248, LES5249, LES5250, LES5251, LES5252, LES5253, LES5254, LES5255, LES5256, LES5257, LES5258, LES5259, LES5260, LES5261, LES5262, LES5263, LES5264, LES5265, LES5266, LES5267, LES5268, LES5269, LES5270, LES5271, LES5272, LES5273, LES5274, LES5275, LES5276, LES5277, LES5278, LES5279, LES5280, LES5282, LES5283, LES5284, LES5285, LES5286, LES5287, LES5288, LES5289, LES5290, LES5291, LES5292, LES5293, LES5294, LES5295, LES5296, LES5297, LES5298, LES5299, LES5300, LES5301, LES5302, LES5303, LES5304, LES5305, LES5306, LES5307, LES5308, LES5309, LES5310, LES5311, LES5312, LES5313, LES5314, LES5315, LES5316, LES5317, LES5318, LES5319, LES5320, LES5321, LES5322, LES5323, LES5324, LES5325, LES5326, LES5327, LES5328, LES5329, LES5330, LES5331, LES5332, LES5333, LES5334, LES5335, LES5336, LES5337, LES5338, LES5339, LES5340, LES5341, LES5342, LES5343, LES5344, LES5345, LES5346, LES5347, LES5348, LES5349, LES5350, LES5351, LES5352, LES5353, LES5354, LES5355, LES5356, LES5357, LES5358, LES5359, LES5360, LES5361, LES5362, LES5363, LES5364, LES5365, LES5366, LES5367, LES5368, LES5369, LES5370, LES5371, LES5372, LES5373, LES5374, LES5375, LES5376, LES5377, LES5378, LES5379, LES5380, LES5381, LES5382, LES5383, LES5384, LES5385, LES5386, LES5387, LES5388, LES5389, LES5390, LES5391, LES5392, LES5393, LES5394, LES5395, LES5396, LES5397, LES5398, LES5399, LES5400, LES5401, LES5402, LES5403, LES5404, LES5405, LES5406, LES5407, LES5408, LES5409, LES5410, LES5411, LES5412, LES5413, LES5414, LES5415, LES5416, LES5417, LES5418, LES5419, LES5420, LES5421, LES5422, LES5423, LES5424, LES5425, LES5426, LES5427, LES5428, LES5429, LES5430, LES5431, LES5432, LES5433, LES5434, LES5435, LES5436, LES5437, LES5438, LES5439, LES5440, LES5441, LES5442, LES5443, LES5444, LES5445, LES5446, LES5447, LES5448, LES5449, LES5450, LES5451, LES5452, LES5453, LES5454, LES5455, LES5456, LES5457, LES5458, LES5459, LES5460, LES5461, LES5462, LES5463, LES5464, LES5465, LES5466, LES5467, LES5468, LES5469, LES5470, LES5471, LES5472, LES5473, LES5474, LES5475, LES5476, LES5477, LES5478, LES5479, LES5480, LES5481, LES5482, LES5483, LES5484, LES5485, LES5486, LES5487, LES5488 and LES5489.
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 East Milham Ave.; Kalamazoo MI 49001
• For Additional Information Contact: 800-800-4236 Ext. 3808
• Manufacturer Reason for Recall: This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded section of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this
• FDA Determined Cause: Component design/selection
• Action: Stryker Instruments sent an Urgent - Medical Device Recall Notification letter dated April 13, 2010, to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Stryker notified customers again on May 24, 2010, and again on September 14, 2010, via email, fax, or telephone. Customers were instructed to locate the units and visually inspect each affected cord. Remove the affected cord and dispose of it using their healthcare facilities disposal procedure. If the cord did not show signs of damage, the unit could remain in service until a replacement cord was available. Customers were to return the enclosed business reply form to confirm receipt of the notification letter and identify how many affected units were currently in their inventory. Stryker instruments would send out replacement cords. If the customer loaned or sold any of the units listed in the notification, the customer was to forward a copy of the notice to the new users and advise Stryker of the new user's name and their new location. If products were disposed of and were no longer in use, the customer was to advise Stryker of their obsolescence by providing them with their serial numbers. For questions regarding this recall call 800-800-4236, ext 3808 or ext 3584 Monday -Friday 8am-5pm (EST).
• Quantity in Commerce: 3364 all products
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Portugal, Canada, China, Taiwan, France, Germany, Greece, Spain, India, Italy, Korea, Switzerland, Singapore, and England.
• 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.

• 510(K) Database: 510(K)s with Product Code = GXD and Original Applicant = VALLEY FORGE SCIENTIFIC CORP.