Spinal Elements Recalls Mercury Spinal System Straight Rods
Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System Straight Rod due to a raw material issue. The affected devices 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 not likely to cause adverse health consequences. The hazard is a raw material issue without reported injuries or illnesses, 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 70mm Straight Rod, Part Number 60101-070. 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 080596. These devices were distributed in Ohio and Pennsylvania.
The source text does not specify specific instructions for consumers or healthcare providers regarding the handling of the recalled devices.
The recalled product
- Product
- Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. 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: 080596
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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