Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component Recalled by Spinal Elements, Inc Due to Some rods may not meet the appropriate traceability...

Date: April 9, 2015
Company: Spinal Elements, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Spinal Elements, Inc directly.

Affected Products

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.

Quantity: 588

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Spinal Elements, Inc

Spinal Elements, Inc has 23 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report