The Recall Desk
ModerateFDA (Devices)·Z-1248-2013·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 Class III by the FDA, which indicates the product is unlikely to cause adverse health consequences. The hazard is a raw material issue without reported injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number 60100-050. The recall is 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 specific lot number is 080584. The affected units were distributed in Ohio and Pennsylvania.

The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for this recall.

The recalled product

Product
Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. 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: 080584

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 →

Related recalls

Same manufacturer · Spinal Elements, Inc

See all →

Same hazard · raw material defect

See all →