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U.S. Department of Health and Human Services

Class 2 Device Recall TiBrid SA Angled Screwdriver

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 Class 2 Device Recall TiBrid SA Angled Screwdriversee related information
Date Initiated by FirmJuly 15, 2024
Date PostedSeptember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2557-2025
Recall Event ID 97402
510(K)NumberK203207 
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
ProductTiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Code Information Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.
FEI Number 3010560653
Recalling Firm/
Manufacturer		 Omnia Medical
6 Canyon Rd Ste 300
Morgantown WV 26508-9232
For Additional Information ContactOmnia Medical Customer service
304-413-4851
Manufacturer Reason
for Recall		Failure of fusion system instruments in the field.
FDA Determined
Cause 2		Device Design
ActionConsignees 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.
Quantity in Commerce15 units
DistributionUS Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OVD
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