TiBrid Fusion Device (Unknown) – Instrument Failure (2024)
Instrument failure may potentially impact medical device performance.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Lot Codes / Batch Numbers
Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5, UDI: 00843511113056, 00843511122287, 00843511122294.
Products Sold
Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
A medical device manufacturer is recalling TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degr due to Failure of fusion system instruments in the field.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure of fusion system instruments in the field.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026