Recall Z-0262-2025— Integra LifeSciences Corp.

Name: FDA recall Z-0262-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-26

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-09-26. It names one FDA 510(k) clearance: K152481. Product: Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694. Reason: Out of specification endotoxin levels..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-26
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K152481 — DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc.·cleared 2015-10-30

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

Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Reason for recall

Out of specification endotoxin levels.

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