Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue
Spinal Elements 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.
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 FDA Class III, which is defined as unlikely to cause adverse health consequences. The source text does not report any injuries or illnesses, and the hazard is described generally as a raw material issue without specific injury reports.
Plain-English summary
Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number 60101-090. 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 080598. These units were distributed in Ohio and Pennsylvania.
The source text does not specify further instructions for consumers or healthcare providers regarding the handling of the recalled devices.
The recalled product
- Product
- Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. 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: 080598
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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