Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue
Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units 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 1/5 (Low).
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 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 400mm Straight Rod, Part Number 60101-400. 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 080602. These units were distributed in Ohio and Pennsylvania.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the use of these products.
The recalled product
- Product
- Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
- Manufacturer
- Spinal Elements, Inc
- 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: 080602
Distribution
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.
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