The Recall Desk
LowFDA (Devices)·Z-1597-2015·Announced 2015-05-20

Spinal Elements Mercury Lordosed Rods Recalled for Missing Traceability Markings

Spinal Elements, Inc. is recalling 588 Mercury lordosed rods because some lack required product identification markings, interrupting device traceability.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and traceability defect rather than a direct physical hazard.

Plain-English summary

Spinal Elements, Inc. is recalling 588 units of the 5.5 x 45MM Mercury lordosed rod, a component of the Mercury Spinal System used for non-cervical spine fixation. The recall is due to traceability issues where some rods were found to lack the product identification number, including the product number and lot number, marked directly on the device.

The absence of these markings interrupts the ability to maintain traceability of the device. The affected units are distributed nationwide, including in Georgia, California, Texas, Colorado, Indiana, North Carolina, Florida, Utah, Tennessee, Missouri, Michigan, Pennsylvania, Ohio, and Oklahoma. The specific part number is 60100-045, and the affected lot numbers are 140086, 140449, and 141013.

This recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.

The recalled product

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 f
Manufacturer
Spinal Elements, Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
588

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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