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Integra® Miltex®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 18-170 · UDI-DI 10381780362500

HNN Prescription
10
510(k) clearances
7,592
Adverse events
155
Recalls
206
Facilities

Description

Integra® Miltex® Barraquer Blade Breaker and Holder, 4-3/8", 13mm Smooth Jaws, Flat Grooved Handle, With Spring Lock

Recalls

DateFirmReason
2026-04-23SSC- Surgical Specialties Corporation3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
2025-08-20MicroSurgical Technology IncAn ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2024-07-15Alcon Research LLCAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

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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.