Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue
Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System lordosed rods 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 2/5 (Moderate).
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 40 MM Lordosed Rod, Part Number 60100-040. The recall is being conducted 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 080583. These units were distributed in Ohio and Pennsylvania.
The source text does not specify the exact nature of the raw material issue or provide instructions for consumers or healthcare providers on how to proceed. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. 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: 080583
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.
See all 21 products in this recall →Related recalls
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