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ZenFlex CM

Kerr Corporation · Model 818-3591 · UDI-DI 00195062145759

EKS Prescription

510(k) clearances

3,963

Adverse events

Recalls

165

Facilities

Description

ZenFlex CM .04/21mm ASSORTED PACK US/CAN Contents: .13/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195062145056, Qty 1 .15/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195062145087, Qty 1 .17/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195062145117, Qty 1 .20/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195062145148, Qty 1 .25/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195062145179, Qty 1 .30/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195062145209, Qty 1

Recalls

Date	Firm	Reason
2025-01-02	US Endodontics, LLC	Due to devices being irradiated above the established specification which my result in package integrity issues.
2012-12-12	Ormco/Sybronendo	The length markings on the Lightspeed LSX files were wrong.
2008-08-01	Ormco Corporation	A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.

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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.