510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0915-2011

Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments...

Stryker Corp. / initiated 2010-04-13 / Terminated / root cause: design
FDA source (opens on fda.gov)

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800)... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0915-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
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.
Product code
GXD Generator, Lesion, Radiofrequency
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
Root cause tag
design
FDA root 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.
Product codes and lots
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.