FDA Device recall Z-1597-2015
Spinal Elements 5.5 x 45MM Mercury lordosed rod
- FDA Device
- Class III
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class III recall of Spinal Elements 5.5 x 45MM Mercury lordosed rod by Spinal Elements, citing 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 an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1597-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-09 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinal Elements |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1597-2015%22
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