Orthopedic Surgical Tool Recall: ConMed Power Pro Handpieces and Cables

The ConMed Linvatec Power Pro, a universal hand tool for orthopedic surgical attachments, has been recalled because it can randomly cause surgical tools to act erratically, potentially causing severe patient injury or death.

The orthopedic surgical tool recall, announced by FDA and ConMed Corporation on September 9, affects certain models of the Pro5 and Pro6 Power Pro Handpieces and their cables. The devices are universal hand tools which can use a variety of orthopedic surgical tool attachments, such as surgical saws and drills.

The recall was issued because the devices have been found to turn on by themselves without the trigger being pressed, stay on even after they’ve been shut off, and can cause the tool to run in unintended directions, potentially causing an orthopedic surgeon to lose control of the instruments during surgery.

ConMed reports that there have been two incidents of “non-serious” injuries to medical personnel due to the problem, but suggested that the personnel may not have followed the proper instructions for use. The medical device manufacturer originally only sent a safety warning to customers, reminding them of proper safety procedures and the potential that the devices could go out of control. Following discussions with the FDA, a voluntary recall was issued this week.

The recall has been classified as an FDA Class I medical device recall, which means that use of the devices carries a reasonable possibility of injury or death. It affects several models of the Power Pro handpieces, both battery-powered and some powered by electric cables, which have been linked to a problem with the devices self-activating.

The recall includes the Power Pro, Power ProMax, and MPower 1 handpieces, with the following catalog numbers: POWER PRO 5100, 5100M, 5200, 5200M, 5250, 5250M, 5300, 5300M, 5400, 5400M, 6200, 6202, 6300, 6400 and 6450. A list of serial numbers is attached to the FDA recall notice.

ConMed indicates that customers will be notified with instructions on how to contact ConMed Linvatec for a schedule to return the defective devices affected by the recall.