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Recall Observatory FDA recall evidence

Device product

TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.

Z-2557-2025

July 15, 2024

Class II

Product summary

Firm
Omnia Medical
Event
Event 97402
Status
Ongoing
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-2557-2025

Official wording

Reason: Failure of fusion system instruments in the field.

Code information: Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failure of fusion system instruments in the field.