Reported Sep 25, 2024 · Ongoing
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion…
Innovasis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Innovasis, Inc · 614 E 3900 S · Salt Lake City, UT · 84107-1902
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number and Description
LS-397-0705 Implant Trial10 x 7 x 28mm x 5¿
- Tx UDI-DI codeM711LS39707050
- Serial Numbers001-012 013-025
- Part Number and Description
LS-397-0805 Implant Trial10 x 8 x 28mm x 5¿
- Tx UDI-DI CodeM711LS39708050
- Serial Numbers001-012 013-026
- Part Number and Description
LS-397-0905 Implant Trial10 x 9 x 28mm x 5¿
- Tx UDI-DI codeM711LS39709050
- Serial Numbers001-012 013-027
- Part Number and Description
LS-397-1005 Implant Trial10 x 10 x 28mm x 5¿
- Tx UDI-Di codeM711LS39710050
- Serial Numbers001-012 013-027
- Part Number and Description
LS-397-1105 Implant Trial10 x 11 x 28mm x 5¿
- Tx UDI-DI codeM711LS39711050
- Serial Numbers001-012 013-027
- Part Number and Description
LS-397-0810 Implant Trial10 x 08 x 28mm x 10¿Tx UDI_DI
- codeM711LS39708100
- Serial Numbers001-012 013-026
- Part Number and Description
LS-397-0910 Implant Trial10 x 09 x 28mm x 10¿
- Tx UDI-DI codeM711LS39709100
- Serial Numbers001-012 013-026
- Part Number and Description
LS-397-1010 Implant Trial10 x 10 x 28mm x 10¿
- Tx UDI-DI codeM711LS39710100
- Serial Numbers001-012 013-026
- Part Number and Description
LS-397-1110 Implant Trial10 x 11 x 28mm x 10¿Tx +M711LS39711100E 001-012 013-026
- Part Number and Description
LS-397-0912 Implant Trial10 x 09 x 28mm x 12.5¿
- Tx UDI-DI codeM711LS39709120
- Serial Numbers001-012 013-024
- Part Number and Description
LS-397-1012 Implant Trial10 x 10 x 28mm x 12.5¿
- Tx UDI-DI codeM711LS39710120
- Serial Numbers001-012 013-024
- Part Number and Description
LS-397-1112 Implant Trial10 x 11 x 28mm x 12.5¿Tx UDI_DI
- codeM711LS39711120
- Serial Numbers001-012 013-025
- Part Number and Description
LS-433-0805 Implant Trial12 x 8 x 32mm x 5¿
- Tx UDI-DI codeM711LS43308050
- Serial Numbers001-012 013-026
- Part Number and Description
LS-433-0905 Implant Trial12 x 9 x 32mm x 5¿
- Tx UDI-DI codeM711LS43309050
- Serial Numbers001-012 013-027
- Part Number and Description
LS-433-1005 Implant Trial12 x 10 x 32mm x 5¿
- Tx UDI-DI codeM711LS43310050
- Serial Numbers001-012 013-027
- Part Number and Description
LS-433-1105 Implant Trial12 x 11 x 32mm x 5¿
- Tx UDI-DI codeM711LS43311050
- Serial Numbers001-012 013-026
- Part Number and Description
LS-433-0910 Implant Trial12 x 09 x 32mm x 10¿
- Tx UDI-DI codeM711LS43309100
- Serial Numbers001-012 013-026
- Part Number and Description
LS-433-1010 Implant Trial12 x 10 x 32mm x 10¿
- Tx UDI-DI codeM711LS43310100
- Serial Numbers001-012 013-028
- Part Number and Description
LS-433-1110 Implant Trial12 x 11 x 32mm x 10¿
- Tx UDI-DI codeM711LS43311100
- Serial Numbers001-012 013-026
- Part Number and Description
LS-433-0912 Implant Trial12 x 09 x 32mm x 12.5¿
- Tx UDI-DI codeM711LS43309120
- Serial Numbers001-012 013-024
- Part Number and Description
LS-433-1012 Implant Trial12 x 10 x 32mm x 12.5¿
- Tx UDI-DI codeM711LS43310120
- Serial Numbers001-012 013-025
- Part Number and Description
LS-433-1112 Implant Trial12 x 11 x 32mm x 12.5¿
- Tx UDI-DI codeM711LS43311120
- Serial Numbers001-012 013-024
- Part Number and Description
- Amount recalled
- 568 devices
Where it was sold
Why it was recalled
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.