Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported May 20, 2015
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.
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 a…
Spinal Elements, Inc recalled Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal Syste… - a low-severity action.
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal Syste… was recalled by Spinal Elements, Inc in May 20, 2015. Reason: Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were fo…. Check the official notice for the remedy. Verify recall #Z-1597-2015 with the FDA Devices before acting.
The recall
Spinal Elements, Inc issued this low-severity FDA Devices recall-Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were fo….
- Low
- severity level
- 588 units
- affected scope
- Class III
- classification
- May 20, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1597-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1597-2015) was formally reported on May 20, 2015, with the manufacturer initiating the action on April 9, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Spinal Elements, Inc is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 588.
The documented reason for this recall is: 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 ro… Distribution data in the federal record shows the product reached: Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
588
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1597-2015 |
| Date reported | May 20, 2015 |
| Date initiated | April 9, 2015 |
| Recalling firm | Spinal Elements, Inc |
| Firm location | Carlsbad, CA |
| Affected scope | 588 |
| Distribution | Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1597-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spinal Elements, Inc. Units affected: 588.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Low. Recall number: Z-1597-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1597-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 20, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.