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Drills, Burrs, Trephines & Accessories (Manual)
FDA product code HBG · Class 2 · Neurology
868
Registered devices
60
Adverse events
54
Recalls
17
510(k) clearances
Devices with this code
Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONQFlow 500 Titanium Bolt-Dual Lumen Bolt Kit — HEMEDEX, INCIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® — INTEGRA PAIN MANAGEMENTIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNA — Synthes GmbHIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONPHASOR — PHASOR HEALTH LLCIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONPHASOR — PHASOR HEALTH LLCIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNA — Synthes GmbHIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Medtronic Neurosurgery | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptabl |
| 2024-04-17 | Integra LifeSciences Corp. | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility |
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