Angled punch awls recalled following failure of fusion system instruments
TiBrid SA Angled Punch Awls in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Punch Awls, used with the TiBrid Stand Alone Intervertebral Body Fusion Device, are being recalled in 30, 45 and 60 degree sizes under model numbers 17-5A-AWL3, 17-5A-AWL4 and 17-5A-AWL5, with UDIs 00843511113056, 00843511122287 and 00843511122294. 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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Manufacturer
- Omnia Medical
- Affected units
- 15
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 (6)
- Model No. 17-5A-AWL3
- 17-5A-AWL4
- 17-5A-AWL5
- UDI: 00843511113056
- 00843511122287
- 00843511122294.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Omnia Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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