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enforcement Primary ID: Z-0767-2014

MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. (UDI Z-0767-2014)

Manufactured by The Anspach Effort, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. - Primary ID Z-0767-2014

Device Regulatory Overview

The MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. (Model/Catalog Number: Unspecified) is a medical device manufactured by The Anspach Effort, Inc.. This product is indexed under FDA Product Code / Category Classification All lots are included in recall 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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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

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ID: Z-2793-2026 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
N/A
Device Name
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
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 MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.?

The registered manufacturer of record for MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. is The Anspach Effort, Inc..

What is the Primary UDI-DI identifier for MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0767-2014.

What classification code is assigned to this device?

This device is registered under product classification code All lots are included in recall.

Similar Classification Devices (All lots are included in recall)

Other Devices by The Anspach Effort, Inc.

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