Spinal Elements 5 — Class III medical device recall Z-1597-2015
Terminated recall by Spinal Elements, Inc, reported 2015-05-20, distributed nationwide. Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were foun
| Recall number | Z-1597-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spinal Elements, Inc, Carlsbad, CA, United States |
| Recall initiated | 2015-04-09 |
| Classified | 2015-05-11 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 588 |
| Lot numbers | 140086, 140449, 141013 |
| Model numbers | 60100-045 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1597-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.