ConMed Linvatec Surgical Tools Ordered Recalled

Several ConMed Linvatec surgical tools and related equipment are being recalled today because the saws and other devices may suddenly turn on or remain running after the trigger is released, posing a risk of injury or death to patients.

The Food and Drug Administration has issued a Class I recall of several surgical products due to defects. A Class I recall is reserved for the most serious cases in which the FDA determines there is a reasonable likelihood of serious injury or death from the recalled products.

The devices have a switch problem where they may self-activate without pushing the trigger, continue running after releasing the trigger, and run in unintended directions, the FDA warned.

According to the FDA, the following surgical products are being recalled:

• 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.

For a full listing of the catalog product numbers and serial numbers of the recalled surgical tools, read the FDA recall notice.

The recalled ConMed hand-held surgical tools were distributed from March 29, 2002 through June 24, 2009. The cables were distributed from January 24, 2001 through February 27, 2009, the FDA said.

Largo, Fla.-based ConMed has already contacted its customers and instructed users to stop using the cable immediately if the handpiece self-activates. Users are being advised to return the handpiece and cable to the company for evaluation.

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