Recall Z-1717-2025— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1717-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Class I · Ongoing

Class I FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-04-11. It names one FDA 510(k) clearance: K073336. Product: CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.. Reason: Inadequate weld that can potentially cause the product to disassemble..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class I
Status: Ongoing
Initiated: 2025-04-11
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K073336 — CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231Codman & Shurtleff, Inc.·cleared 2008-01-04

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

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

Reason for recall

Inadequate weld that can potentially cause the product to disassemble.

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