Spinal Elements, Inc recalls Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of sc…

Recall date

April 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1597-2015

FDA classification

Class III

Brand / firm

Spinal Elements, Inc

Sold / distributed

Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.

Why it was recalled

Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.