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 | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Product | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. |
| Quantity | 68 units total |
| Distribution | Distributed in OH and PA. |
| Initiated | 2009-04-17 |
| Classified | 2013-05-07 |
| Terminated | 2013-05-07 |
| Recall number | Z-1255-2013 |
| 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-1255-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/53487/
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