The Recall Desk
LowFDA (Devices)·Z-1249-2013·Announced 2013-05-15

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

Spinal Elements is recalling 68 units of the Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod due to a raw material issue.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because they are unlikely to cause adverse health consequences. No injuries or illnesses are reported in the source text.

Plain-English summary

Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number 60100-060. The recall involves 68 units of the device, which is 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 are identified by Lot Number 080585. These devices were distributed in Ohio and Pennsylvania.

The source text does not specify specific instructions for consumers or patients regarding the recall, nor does it report any illnesses or injuries associated with the use of these devices.

The recalled product

Product
Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. 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: 080585

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 issue

See all →