Recall Z-1716-2025— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1716-2025
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: K183581. Product: CODMAN Disposable Perforator, 14mm. Cranial perforator.. 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

K183581 — Codman Disposable PerforatorsIntegra Lifesciences Corp.·cleared 2019-01-20

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 Disposable Perforator, 14mm. Cranial perforator.

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.