Angled screwdrivers recalled after fusion system instruments failed in the field
TiBrid SA Angled Screwdrivers in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; instrument failure during a spinal fusion procedure is a potential harm and no injuries are reported.
Plain-English summary
TiBrid SA Angled Screwdrivers, used with the TiBrid Stand Alone Intervertebral Body Fusion Device, are being recalled in 30, 45 and 60 degree angles under model numbers 17-5A-DV45 and 17-5A-DV60, with UDIs 00843511122041, 00843511122058 and 00843511122065. The recall covers 15 units distributed in Arizona, California, New Jersey, Nevada, Oklahoma and Washington.
The recall was issued because of failure of fusion system instruments in the field. The FDA classified the action as Class II.
Hospitals and surgical centres holding these instruments should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
- Manufacturer
- Omnia Medical
- Hazard
- instrument-failure
- spinal-fusion
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model No. 17-5A-DV45
- 17-5A-DV60
- UDI: 00843511122041
- 00843511122058
- 00843511122065.
Distribution
Distributed nationwide across the United States.
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