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Open, Classified

TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

FDA Recall Z-2556-2025 · Posted 2025-09-11

Recalling FirmOmnia Medical
Recall StatusOpen, Classified
Product CodeOVD
Date Initiated2024-07-15
Product Quantity15 units

Reason for Recall

Failure of fusion system instruments in the field.

Firm Action

Consignees were called on or around 8/1/2024 to notify them of this recall of instruments. Affected instruments were to be sent back to Omnia Medical and replaced with instruments that underwent rework in the form of design changes aimed at increasing their durability.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203207Omnia Medical TiBrid-SAOmnia Medical, LLC · 2020-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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