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enforcement Primary ID: Z-0455-2018

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM (UDI Z-0455-2018)

Manufactured by Zimmer Biomet, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM - Primary ID Z-0455-2018

Device Regulatory Overview

The Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM (Model/Catalog Number: Unspecified) is a medical device manufactured by Zimmer Biomet, Inc.. This product is indexed under FDA Product Code / Category Classification Item No. 814309320; Lot No. (Exp. Date) UDI: 669850 (06/15/2027) UDI (01)00887868038006 (17)270615 (10)669850; 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

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Technical Specifications

Model Number
N/A
Device Name
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Database Sync Date
2026-08-09 10:06:38

Full Regulatory Attributes

🔒 Token Gated 
{
    "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 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM?

The registered manufacturer of record for Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM is Zimmer Biomet, Inc..

What is the Primary UDI-DI identifier for Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0455-2018.

What classification code is assigned to this device?

This device is registered under product classification code Item No. 814309320; Lot No. (Exp. Date) UDI: 669850 (06/15/2027) UDI (01)00887868038006 (17)270615 (10)669850; 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670.

Other Devices by Zimmer Biomet, Inc.

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