Events

Recall of SmartPump Tourniquet Stystem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56624
  • Event Risk Class
    Class 2
  • Event Number
    Z-0915-2011
  • Event Initiated Date
    2010-04-13
  • Event Date Posted
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95640
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Generator, lesion, radiofrequency - Product Code GXD
  • Reason
    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.
  • 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).

Device

SmartPump Tourniquet Stystem
  • Model / Serial
    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.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA