Recall Z-0493-2024— Integra LifeSciences Corp.

Name: FDA recall Z-0493-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-19

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2023-10-19. It names one FDA 510(k) clearance: K961113. Product: Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040. Reason: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-19
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILLClinical Neuro Systems, LLC·cleared 1996-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

Reason for recall

Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

Data sourced from openFDA. This site is unofficial and independent of the FDA.