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Integra® Miltex®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 11-684 · UDI-DI 10381780128366

HBG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Integra® Miltex® Beckman-Adson Retractor, 12-1/4", 4*4 Prongs, 28mm Wide, 29.5mm Deep, Sharp

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 acceptable limit for devices
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 maybe compromised.
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 maybe compromised.
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 maybe compromised.
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 maybe compromised.
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 maybe compromised.
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 maybe compromised.
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 maybe compromised.
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 maybe compromised.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.