BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-3163-2024 · Reported September 25, 2024

    Enforcement

    Recall Number
    Z-3163-2024
    Event ID
    95185
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Innovasis, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2024
    Initiation Date
    August 14, 2024
    Classification Date
    September 17, 2024
    Address
    614 E 3900 S, Salt Lake City, UT, 84107-1902, United States

    Description

    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.

    Reason

    Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.

    Code Info

    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

    Distribution

    U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.

    Quantity

    568 devices