Spinal Elements Recalls Mercury Spinal System Straight Rods
Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The devices were distributed in Ohio and Pennsylvania.
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 these recalls are unlikely to cause adverse health consequences.
Plain-English summary
Spinal Elements, Inc. has initiated a recall for the Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number 60101-050. The recall involves 68 units from Lot Number 080594. These medical devices are 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 were distributed in Ohio and Pennsylvania. The source text does not specify the exact nature of the raw material defect or any reported adverse events.
Healthcare providers and patients who have received these specific spinal rods should contact Spinal Elements, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. 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: 080594
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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