Class III — Spinal Elements, Inc
| Recalling firm | Spinal Elements |
|---|---|
| Registered facility | SPINAL ELEMENTS, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| Product | 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 |
| Distribution | Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK. |
| Initiated | 2015-04-09 |
| Classified | 2015-05-11 |
| Terminated | 2015-06-25 |
| Recall number | Z-1597-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Spinal Elements, Inc (Z-1597-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70950/
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