The Recall Desk
ModerateFDA (Devices)·Z-1261-2013·Announced 2013-05-15

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

Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System straight rods due to a raw material issue. The affected devices 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 the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a raw material issue without reported injuries.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number 60101-080. The recall was initiated due to a raw material issue. The affected product is intended to provide immobilization and stabilization of the spine in skeletally mature patients.

A total of 68 units are involved in this recall, identified by Lot Number 080597. These devices were distributed in Ohio and Pennsylvania. The recall is classified as Class III by the U.S. Food and Drug Administration, which indicates that the product is not likely to cause adverse health consequences.

Healthcare providers and patients who have received or used these specific spinal rods 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 80mm Straight Rod, Part Number: 60101-080. 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: 080597

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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