The U.S. Food and Drug Administration (FDA) is advising orthopedic surgical healthcare professionals, hospital risk managers, and surgical service managers that ConMed Linvatec-Universal Cables and Power Pro Handpieces are being recalled. The FDA notified healthcare professionals of the Class 1 recall of two ConMed Linvatec surgical service products due to reports of a switch problem resulting in unintended self-activation of these powered tools, continued running after trigger release, and tool movement in unintended directions. The products are:
* Power Pro, Power ProMax, and MPower 1 Handpieces, powered surgical handpieces in which a number of surgical tools (such as drills, blades, and small cutting devices) can be attached and are used during orthopedic surgical procedures.
* Universal Cables, MC5057, the cable connects Linvatec MicroChoice Small Bone, MicroChoice, Advantage and APEX Shaver System and Power Pro Electric I and II Large Bone System electric handpieces to the power source.
The recalled handpieces were distributed from March 29, 2002 through June 24, 2009; the cables were distributed from January 24, 2001 through February 27, 2009.
ConMed has instructed users to stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs, and to return the handpiece and cable to the company for evaluation.
Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; by telephone, toll-free at: 1-800-332-1088; or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178]. FDA Form 3500 is explained and can be accessed at: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm.
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