TxHA PEEK IBF/TxTiHA IBF System recall
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…
Why was TxHA PEEK IBF/TxTiHA IBF System recalled?
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Innovasis, Inc
- Quantity
- 568 devices
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)