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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70950

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 09, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Spinal Elements, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1597-2015
Recall number
Z-1597-2015
Initiated
April 09, 2015
Classification
Class III
Status
Terminated
Recalling firm
Spinal Elements, Inc
Quantity
588

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013

Distribution pattern

Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.