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Shunt, Central Nervous System And Components

FDA product code JXG · Class 2 · Neurology

4,095
Registered devices
25,418
Adverse events
108
Recalls
259
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-04-10Integra LifeSciences Corp. (NeuroSciences)Out-of-specification endotoxin result that did not meet the acceptance criteria.
2024-12-16Integra LifeSciences Corp.Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16Integra LifeSciences Corp.Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16Integra LifeSciences Corp.Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-05-07Integra LifeSciences Corp.Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2024-05-07Integra LifeSciences Corp.Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
2024-05-07Integra LifeSciences Corp.Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2023-11-28Natus Medical IncorporatedSterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-11-28Natus Medical IncorporatedSterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-06-28Medtronic NeurosurgeryProduct labeling contains incorrect expiration date

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.