The Recall Desk
ModerateFDA (Devices)·Z-1263-2013·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 100mm Straight Rod due to a raw material issue.

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 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, fitting the criteria for a moderate or low-risk precautionary recall.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number 60101-100. The recall involves 68 units total, identified by Lot Number 080599. These devices are 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 source text does not specify the exact nature of the raw material defect or any reported adverse events or injuries.

Healthcare providers and patients who have received this specific device 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 Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Manufacturer
Spinal Elements, Inc
Category
Medical Device — Orthopedic / Spinal
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: 080599

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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