Recall Z-2557-2025— Omnia Medical

Name: FDA recall Z-2557-2025
Creator: U.S. Food and Drug Administration
Published: 2024-07-15

Class II · Ongoing

Class II FDA medical device recall by Omnia Medical, initiated 2024-07-15. It names one FDA 510(k) clearance: K203207. Product: TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.. Reason: Failure of fusion system instruments in the field..

Recalling firm: Omnia Medical
Classification: Class II
Status: Ongoing
Initiated: 2024-07-15
Firm location: Morgantown, WV, United States

510(k) clearances named in this recall

1 on FDA's record

K203207 — Omnia Medical TiBrid-SAOmnia Medical, LLC·cleared 2020-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Failure of fusion system instruments in the field.

Data sourced from openFDA. This site is unofficial and independent of the FDA.