The Recall Desk
ModerateFDA (Devices)·Z-1253-2013·Announced 2013-05-15

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

Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The source text does not report any injuries or illnesses, and the hazard is a raw material issue without specified clinical impact, fitting the criteria for a moderate or low-risk precautionary recall.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for 68 units of the Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number 60100-100. The recall was initiated due to a raw material issue. The product is intended to provide immobilization and stabilization of the spine in skeletally mature patients.

The affected units, identified by Lot Number 080589, were distributed in Ohio and Pennsylvania. The source text does not specify the exact nature of the raw material defect or any reported adverse events.

Consumers and healthcare providers who have purchased or used these specific units 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 100mm Lordosed Rod, Part Number: 60100-100. 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: 080589

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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