Spinal Elements, Inc: Medical Device Recall in 2015 - (Recall #: Z-1597-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: April 9, 2015

Date Posted: May 20, 2015

Recall Number: Z-1597-2015

Event ID: 70950

Reason for Recall:

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.

Status: Terminated

Product Quantity: 588

Code Information:

Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated