The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-1250-2013·Announced 2013-05-15

Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod due to a raw material issue.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The agency classification is Class III, which the rubric defines as typically unlikely to cause adverse health consequences, resulting in a score of 1.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number 60100-070. The recall involves 68 units of the device, which is intended to provide immobilization and stabilization of the spine in skeletally mature patients.

The recall was initiated due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania. The specific lot number for the recalled product is 080586.

Consumers and healthcare providers who have this specific product should contact Spinal Elements, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Manufacturer
Spinal Elements, Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
68

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 (1)

  • Lot number: 080586

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 21 recalled by Spinal Elements, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

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