Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Why it was recalled
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Part Number and Description: LS-397-0705 Implant Trial, 10 x 7 x 28mm x 5¿, Tx UDI-DI code: M711LS39707050 Serial Numbers: 001-012 013-025 Part Number and Description: LS-397-0805 Implant Trial, 10 x 8 x 28mm x 5¿, Tx UDI-DI Code: M711LS39708050 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-0905 Implant Trial, 10 x 9 x 28mm x 5¿, Tx UDI-DI code: M711LS39709050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-397-1005 Implant Trial, 10 x 10 x 28mm x 5¿, Tx UDI-Di code: M711LS39710050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-397-1105 Implant Trial, 10 x 11 x 28mm x 5¿, Tx UDI-DI code: M711LS39711050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-397-0810 Implant Trial, 10 x 08 x 28mm x 10¿, Tx UDI_DI code: M711LS39708100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-0910 Implant Trial, 10 x 09 x 28mm x 10¿, Tx UDI-DI code: M711LS39709100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-1010 Implant Trial, 10 x 10 x 28mm x 10¿, Tx UDI-DI code: M711LS39710100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-397-1110 Implant Trial, 10 x 11 x 28mm x 10¿, Tx +M711LS39711100E 001-012 013-026 Part Number and Description: LS-397-0912 Implant Trial, 10 x 09 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39709120 Serial Numbers: 001-012 013-024 Part Number and Description: LS-397-1012 Implant Trial, 10 x 10 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39710120 Serial Numbers: 001-012 013-024 Part Number and Description: LS-397-1112 Implant Trial, 10 x 11 x 28mm x 12.5¿, Tx UDI_DI code: M711LS39711120 Serial Numbers: 001-012 013-025 Part Number and Description: LS-433-0805 Implant Trial, 12 x 8 x 32mm x 5¿, Tx UDI-DI code: M711LS43308050 Serial Numbers: 001-012 013-026 Part Number and Description: LS-433-0905 Implant Trial, 12 x 9 x 32mm x 5¿, Tx UDI-DI code: M711LS43309050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-433-1005 Implant Trial, 12 x 10 x 32mm x 5¿, Tx UDI-DI code: M711LS43310050 Serial Numbers: 001-012 013-027 Part Number and Description: LS-433-1105 Implant Trial, 12 x 11 x 32mm x 5¿, Tx UDI-DI code: M711LS43311050 Serial Numbers: 001-012 013-026 Part Number and Description: LS-433-0910 Implant Trial, 12 x 09 x 32mm x 10¿, Tx UDI-DI code: M711LS43309100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-433-1010 Implant Trial, 12 x 10 x 32mm x 10¿, Tx UDI-DI code: M711LS43310100 Serial Numbers: 001-012 013-028 Part Number and Description: LS-433-1110 Implant Trial, 12 x 11 x 32mm x 10¿, Tx UDI-DI code: M711LS43311100 Serial Numbers: 001-012 013-026 Part Number and Description: LS-433-0912 Implant Trial, 12 x 09 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43309120 Serial Numbers: 001-012 013-024 Part Number and Description: LS-433-1012 Implant Trial, 12 x 10 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43310120 Serial Numbers: 001-012 013-025 Part Number and Description: LS-433-1112 Implant Trial, 12 x 11 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43311120 Serial Numbers: 001-012 013-024
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
Recall record
- Recalling firm
- Innovasis, Inc
- Product type
- Devices
- Recall number
- Z-3163-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Salt Lake City, UT
- Recall initiated
- 2024-08-14
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-3163-2024 · Source: openFDA enforcement.