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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Spinal Elements, Inc: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Agency Publication Date: May 7, 2013
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Affected Products

Product: Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080582

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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.

Lot Number: 080583

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Product: Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080584

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Number
Product: Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080585

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Product: Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot number: 080586

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Product: Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot number: 080587

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Product: Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080588

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Product: Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080589

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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.

Lot number: 080590

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Product: Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080591

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Product: Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot number: 080592

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number
Product: Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080593

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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.

Lot Number: 080594

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Product: Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080594

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Number
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.

Lot Number: 080596

Lot Numbers:
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Product: Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080597

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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.

Lot Number: 080598

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Product: Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080599

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Number
Product: Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080600

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Product: Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080601

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Product: Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Lot Number: 080602

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Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 53487
Status: Resolved
Manufacturer: Spinal Elements, Inc
Manufactured In: United States
Units Affected: 21 products (68 units total)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.