The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Devices)·Z-1257-2013·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 straight rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

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 2/5 (Moderate).

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 Class III by the FDA, which indicates the product is not likely to cause adverse health consequences. The hazard is a raw material issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number 60101-040. The recall is being conducted due to a raw material issue. The product is intended to provide immobilization and stabilization of the spine in skeletally mature patients.

A total of 68 units are affected by this recall. The devices were distributed in Ohio and Pennsylvania. The specific lot number for the recalled product is 080593.

The source text does not specify the exact nature of the raw material issue or provide specific instructions for consumers or healthcare providers on how to handle the recalled devices. Patients who have had this device implanted should contact their healthcare provider for guidance.

The recalled product

Product
Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Manufacturer
Spinal Elements, Inc
Category
Medical Device — Orthopedic 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: 080593

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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