Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue
Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod due to a raw material issue. The affected units 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 such 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 110mm Lordosed Rod, Part Number 60100-110. 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 080590. 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 these devices.
The recalled product
- Product
- Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
- Manufacturer
- Spinal Elements, Inc
- Category
- Medical Device — Spinal Implant
- 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: 080590
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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See all →- LowSpinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue
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