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Integra® Miltex®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 012-S4003 · UDI-DI 10381780484455
EKS
Prescription
10
510(k) clearances
3,925
Adverse events
3
Recalls
165
Facilities
Description
Flex-R® Files - Flexible Roane Tip w/Stop #10 21mm
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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