—#95640

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.

FDA product code: GXD — Generator, Lesion, Radiofrequency
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K032601
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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).

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 East Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Portugal, Canada, China, Taiwan, France, Germany, Greece, Spain, India, Italy, Korea, Switzerland, Singapore, and England.

Timeline

Recall initiated: 2010-04-13
Posted by FDA: 2011-01-18
Terminated: 2011-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.