RETRACTOR 245MM X 60MM MALLEABLE 41,0CM

RETRACTOR • 245MM X 60MM FLEXIBLE • 41.0CM • CE-CLASS I • ISO 13485:2016

Professional Mega-Wide Flexible Retractor for Maximal, Tissue-Sparing Exposure of Extensive Surgical Fields in Reconstructive Major Surgery, Orthopedic Tumor Surgery and Complex Traumatology

The RETRACTOR 245 mm x 60 mm / 41.0 cm is a Class I medical device manufactured according to ISO 13485:2016. With an exceptional blade width of 60 mm, this mega-flex retractor represents the specialized solution for the most demanding surgical scenarios requiring ultimate, broad, and anatomically perfectly adapted retraction. Its unique dimensions enable the exposure and protection of the largest wound areas with minimal tissue trauma.

Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Mega-wide, highly flexible blade (245 mm x 60 mm) – Maximum available contact area for ultimate pressure distribution
✔ Optimal lever length of 41.0 cm for deep access in major reconstructions
✔ High-quality, surgical special spring steel – Designed for maximum malleability with high material fatigue limit
✔ Fully atraumatic, polished round-edge construction on all sides for maximum tissue protection
✔ Robust, ergonomically shaped double-T handle with widened contact surface for powerful and controlled two-handed guidance
✔ High-quality satin finish for glare-free visualization
✔ Special material refinement guarantees shape stability and reversible bending properties over numerous sterilization cycles
✔ Sterilizable and reusable

Benefits of the 60 mm Mega-Wide Flexible Retractor:

• Ultimate Tissue Sparing: The 60 mm wide contact surface distributes retraction pressure so evenly that even delicate tissue (skin flaps, muscle) is optimally protected.
• Perfect Adaptation to Macro-Anatomical Structures: Ideal instrument for custom contouring to large body regions such as entire thoracic halves, iliac wings, or large joint areas.
• Maximum Surgical Field Overview: Enables exposure and coverage of extremely large wound areas with a minimal number of retractors and assistants.
• Indispensable in Specialized Disciplines: Particularly valuable in reconstructive microsurgery (e.g., for positioning DIEP or ALT flaps), orthopedic soft tissue tumor resection, and complex traumatic soft tissue defects.
• Efficiency Enhancement in Complex Procedures: Reduces instrumental tissue fatigue, shortens preparation time, and improves ergonomics for the surgical team.

Technical Specifications:

• Type: Mega-Wide Flexible Retractor / Ultra-Wide Malleable Retractor
• Blade Dimensions: 245 mm (Length) x 60 mm (Width)
• Overall Length: 41.0 cm
• Blade Property: Highly flexible, manually formable, with shape memory
• Material: Specially alloyed spring steel of surgical grade
• Surface Finish: Satin premium finish
• Handle: Widened double-T handle with ergonomic angulation
• Sterilization: Autoclavable up to 138°C (Steam Sterilization)
• Packaging: Individually packed in sterilizable special packaging with supportive forming rail to prevent transport and storage damage
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Areas of Application:

• Major Plastic and Reconstructive Surgery (e.g., free flap transfers, chest wall reconstructions, complex abdominal wall reconstructions)
• Orthopedic Soft Tissue Tumor Surgery on extremities and trunk
• Trauma Surgical Management of Extensive Soft Tissue Injuries (e.g., debridement in Necrotizing Fasciitis)
• Revision Surgery after Major Joint Replacement
• Special Visceral Procedures with Extremely Large Access (e.g., liver transplantation, multivisceral resections)

Important Safety and Handling Information (Critical Warnings):

• FOR USE BY SPECIALIZED SURGEONS IN HIGHLY COMPLEX PROCEDURES ONLY. Requires specific experience in handling large retractors.
• Bending Technique: Shape the blade using both hands with even force distribution only and in very slow, controlled movements. Absolutely prohibit quick, jerky movements or bending over edges. The extreme width makes the instrument more susceptible to material fatigue if handled improperly.
• Material Fatigue Inspection: Before EACH use, a careful visual and functional inspection for micro-cracks, fatigue lines, or permanent deformations across the entire blade area and at the handle junction is MANDATORY.
• Reprocessing: Pre-clean the instrument immediately after use. During automated reprocessing, place it in special, large-area mesh trays that ensure flat lying. Clean manually only with soft brushes and without pressure.
• Storage: Must be stored completely flat and straight in specially designed storage rails or on level surfaces. Any sharp bend during storage can lead to permanent deformation.
• Sterilization Requirement: Requires large-volume sterilization containers with flat inserts. The instrument must not be kinked or laid over other instruments.