Recall Z-2556-2025— Omnia Medical

Name: FDA recall Z-2556-2025
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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.. 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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

Reason for recall

Failure of fusion system instruments in the field.

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