|
ConMed Linvatec - Universal Cables and Power Pro Handpieces
Audience: Orthopedic surgical healthcare professionals, hospital risk managers, surgical service managers
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 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, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].
Read the complete MedWatch 2009 Safety summary, including links to the two recall notices and the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181833.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
