eudamed_udi Primary ID: 09421028116992

Enztec Charnley - Spiked Fixed Blade Retractor - 50mm (UDI 09421028116992)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Enztec Charnley - Spiked Fixed Blade Retractor - 50mm (Model/Catalog Number: 4050-0191) is a medical device manufactured by Enztec Limited. This product is indexed under FDA Product Code / Category Classification L0915 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0612-2020 View Full Alert →

REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE...

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Technical Specifications

Model Number: 4050-0191
Product Code / EMDN: L0915
Device Name: Retractors and Frames
Database Sync Date: 2026-08-09 16:29:45

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Enztec Charnley - Spiked Fixed Blade Retractor - 50mm?

The registered manufacturer of record for Enztec Charnley - Spiked Fixed Blade Retractor - 50mm is Enztec Limited.

What is the Primary UDI-DI identifier for Enztec Charnley - Spiked Fixed Blade Retractor - 50mm?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09421028116992.

What classification code is assigned to this device?

This device is registered under product classification code L0915.

Similar Classification Devices (L0915)

Other Devices by Enztec Limited

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