Z-3163-2024Class II

TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral...

Name: Z-3163-2024 TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral...
Creator: Innovasis, Inc
Published: 2024-08-14
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2024-08-14 / Open, Classified / root cause: design

FDA source

Innovasis, Inc began a recall of 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... on 2024-08-14. FDA classified it as Class II and gives the reason as "Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3163-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-14
Posted: 2024-09-17
Recalling firm: Innovasis, Inc
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 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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Root cause tag: design
FDA root cause: Device Design
Action: On 08/14/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them of interfacing issues between the implant trial and inserter of the Tx Systems. Customers are instructed to: 1. Please return trial sets to Innovasis for proper disposition. 2. Innovasis Distributor & Product Support (DPS) personnel will coordinate product replenishment with customers as needed. 3. Once all affected parts have been removed from inventory, a Product Removal Form will be issued to customers. This form must be filled, signed and returned for regulatory purposes. Note that this may come from an e-signature application (e.g., Adobe Sign, RightSignature, etc.). For questions/assistance, contact DPS at 801-261-2242 or [email protected] during business hours Monday thru Friday 8:00 a.m. - 5:00 p.m. MST.
Quantity in commerce: 568 devices
Distribution: U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3163-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3163-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-17

Product code MAX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)