Innovasis, Inc: Lumbar Fusion Device Implant Trials Recalled for Inserter Interfacing Issues

Agency Publication Date: September 17, 2024

Summary

Innovasis, Inc. is recalling 568 units of its TxHA PEEK IBF and TxTiHA IBF System Implant Trials due to mechanical interfacing issues between the trial device and the inserter tool used during spinal surgery. These devices are intended to help surgeons stabilize spinal segments and promote fusion to reduce pain. Because the trial may not connect correctly to the insertion tool, surgeons should contact the manufacturer immediately for guidance. This recall affects various sizes and angles of the lumbar intervertebral fusion device trials distributed across nine U.S. states.

Risk

A failure in the interface between the implant trial and the inserter can cause the device to function improperly during spinal surgery, potentially leading to surgical delays or complications during the placement of the fusion device. While no specific injuries are mentioned, the mechanical issue poses a risk to patients undergoing orthopedic spinal procedures.

What You Should Do

Identify if your medical facility has the affected TxHA or TxTiHA Implant Trials by checking the Part Numbers (ranging from LS-397-0705 to LS-433-1112) and their corresponding Serial Numbers and UDI-DI codes printed on the device or packaging.
Check specifically for UDI-DI codes including M711LS39707050, M711LS39708050, M711LS39709050, M711LS39710050, M711LS39711050, M711LS39708100, M711LS39709100, M711LS39710100, M711LS39709120, M711LS39710120, M711LS39711120, M711LS43308050, M711LS43309050, M711LS43310050, M711LS43311120, and related series listed in the product details.
Immediately stop using the affected implant trials and quarantine them to prevent use in upcoming surgical procedures.
Contact Innovasis, Inc. directly at their Salt Lake City headquarters or through your local representative to arrange for the return of affected devices and to receive further instructions regarding potential replacements.
Physicians and surgical staff should contact their healthcare provider or the manufacturer for further instructions regarding any clinical concerns related to previously used devices.
For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction/instruction following identified interfacing issues.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Implant Trial, 10 x 7 x 28mm x 5°, Tx

Model / REF:

LS-397-0705

Lot Numbers:

M711LS39707050

Serial Numbers: 001-012, 013-025

Product: Implant Trial, 10 x 8 x 28mm x 5°, Tx

Model / REF:

LS-397-0805

Lot Numbers:

M711LS39708050

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 9 x 28mm x 5°, Tx

Model / REF:

LS-397-0905

Lot Numbers:

M711LS39709050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 10 x 10 x 28mm x 5°, Tx

Model / REF:

LS-397-1005

Lot Numbers:

M711LS39710050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 10 x 11 x 28mm x 5°, Tx

Model / REF:

LS-397-1105

Lot Numbers:

M711LS39711120

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 10 x 08 x 28mm x 10°, Tx

Model / REF:

LS-397-0810

Lot Numbers:

M711LS39708100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 09 x 28mm x 10°, Tx

Model / REF:

LS-397-0910

Lot Numbers:

M711LS39709100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 10 x 28mm x 10°, Tx

Model / REF:

LS-397-1010

Lot Numbers:

M711LS39710100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 11 x 28mm x 10°, Tx

Model / REF:

LS-397-1110

Lot Numbers:

M711LS39711100E

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 09 x 28mm x 12.5°, Tx

Model / REF:

LS-397-0912

Lot Numbers:

M711LS39709120

Serial Numbers: 001-012, 013-024

Product: Implant Trial, 10 x 10 x 28mm x 12.5°, Tx

Model / REF:

LS-397-1012

Lot Numbers:

M711LS39710120

Serial Numbers: 001-012, 013-024

Product: Implant Trial, 10 x 11 x 28mm x 12.5°, Tx

Model / REF:

LS-397-1112

Lot Numbers:

M711LS39711120

Serial Numbers: 001-012, 013-025

Product: Implant Trial, 12 x 8 x 32mm x 5°, Tx

Model / REF:

LS-433-0805

Lot Numbers:

M711LS43308050

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 9 x 32mm x 5°, Tx

Model / REF:

LS-433-0905

Lot Numbers:

M711LS43309050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 12 x 10 x 32mm x 5°, Tx

Model / REF:

LS-433-1005

Lot Numbers:

M711LS43310050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 12 x 11 x 32mm x 5°, Tx

Model / REF:

LS-433-1105

Lot Numbers:

M711LS43311050

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 09 x 32mm x 10°, Tx

Model / REF:

LS-433-0910

Lot Numbers:

M711LS43309100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 10 x 32mm x 10°, Tx

Model / REF:

LS-433-1010

Lot Numbers:

M711LS43310100

Serial Numbers: 001-012, 013-028

Product: Implant Trial, 12 x 11 x 32mm x 10°, Tx

Model / REF:

LS-433-1110

Lot Numbers:

M711LS43311100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 09 x 32mm x 12.5°, Tx

Model / REF:

LS-433-0912

Lot Numbers:

M711LS43309120

Serial Numbers: 001-012, 013-024

Product: Implant Trial, 12 x 10 x 32mm x 12.5°, Tx

Model / REF:

LS-433-1012

Lot Numbers:

M711LS43310120

Serial Numbers: 001-012, 013-025

Product: Implant Trial, 12 x 11 x 32mm x 12.5°, Tx

Model / REF:

LS-433-1112

Lot Numbers:

M711LS43311120

Serial Numbers: 001-012, 013-024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95185

Status: Active

Manufacturer: Innovasis, Inc

Sold By: Hospitals; Surgical sites; Orthopedic surgeons

Manufactured In: United States

Units Affected: 568 devices

Distributed To: Alabama, California, Colorado, Florida, Idaho, Michigan, South Dakota, Texas, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if your medical facility has the affected TxHA or TxTiHA Implant Trials by checking the Part Numbers (ranging from LS-397-0705 to LS-433-1112) and their corresponding Serial Numbers and UDI-DI codes printed on the device or packaging.

Check specifically for UDI-DI codes including M711LS39707050, M711LS39708050, M711LS39709050, M711LS39710050, M711LS39711050, M711LS39708100, M711LS39709100, M711LS39710100, M711LS39709120, M711LS39710120, M711LS39711120, M711LS43308050, M711LS43309050, M711LS43310050, M711LS43311120, and related series listed in the product details.

Immediately stop using the affected implant trials and quarantine them to prevent use in upcoming surgical procedures.

Contact Innovasis, Inc. directly at their Salt Lake City headquarters or through your local representative to arrange for the return of affected devices and to receive further instructions regarding potential replacements.

Physicians and surgical staff should contact their healthcare provider or the manufacturer for further instructions regarding any clinical concerns related to previously used devices.

For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Implant Trial, 10 x 7 x 28mm x 5°, Tx

Model / REF:

LS-397-0705

Lot Numbers:

M711LS39707050

Serial Numbers: 001-012, 013-025

Product: Implant Trial, 10 x 8 x 28mm x 5°, Tx

Model / REF:

LS-397-0805

Lot Numbers:

M711LS39708050

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 9 x 28mm x 5°, Tx

Model / REF:

LS-397-0905

Lot Numbers:

M711LS39709050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 10 x 10 x 28mm x 5°, Tx

Model / REF:

LS-397-1005

Lot Numbers:

M711LS39710050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 10 x 11 x 28mm x 5°, Tx

Model / REF:

LS-397-1105

Lot Numbers:

M711LS39711120

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 10 x 08 x 28mm x 10°, Tx

Model / REF:

LS-397-0810

Lot Numbers:

M711LS39708100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 09 x 28mm x 10°, Tx

Model / REF:

LS-397-0910

Lot Numbers:

M711LS39709100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 10 x 28mm x 10°, Tx

Model / REF:

LS-397-1010

Lot Numbers:

M711LS39710100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 11 x 28mm x 10°, Tx

Model / REF:

LS-397-1110

Lot Numbers:

M711LS39711100E

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 10 x 09 x 28mm x 12.5°, Tx

Model / REF:

LS-397-0912

Lot Numbers:

M711LS39709120

Serial Numbers: 001-012, 013-024

Product: Implant Trial, 10 x 10 x 28mm x 12.5°, Tx

Model / REF:

LS-397-1012

Lot Numbers:

M711LS39710120

Serial Numbers: 001-012, 013-024

Product: Implant Trial, 10 x 11 x 28mm x 12.5°, Tx

Model / REF:

LS-397-1112

Lot Numbers:

M711LS39711120

Serial Numbers: 001-012, 013-025

Product: Implant Trial, 12 x 8 x 32mm x 5°, Tx

Model / REF:

LS-433-0805

Lot Numbers:

M711LS43308050

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 9 x 32mm x 5°, Tx

Model / REF:

LS-433-0905

Lot Numbers:

M711LS43309050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 12 x 10 x 32mm x 5°, Tx

Model / REF:

LS-433-1005

Lot Numbers:

M711LS43310050

Serial Numbers: 001-012, 013-027

Product: Implant Trial, 12 x 11 x 32mm x 5°, Tx

Model / REF:

LS-433-1105

Lot Numbers:

M711LS43311050

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 09 x 32mm x 10°, Tx

Model / REF:

LS-433-0910

Lot Numbers:

M711LS43309100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 10 x 32mm x 10°, Tx

Model / REF:

LS-433-1010

Lot Numbers:

M711LS43310100

Serial Numbers: 001-012, 013-028

Product: Implant Trial, 12 x 11 x 32mm x 10°, Tx

Model / REF:

LS-433-1110

Lot Numbers:

M711LS43311100

Serial Numbers: 001-012, 013-026

Product: Implant Trial, 12 x 09 x 32mm x 12.5°, Tx

Model / REF:

LS-433-0912

Lot Numbers:

M711LS43309120

Serial Numbers: 001-012, 013-024

Product: Implant Trial, 12 x 10 x 32mm x 12.5°, Tx

Model / REF:

LS-433-1012

Lot Numbers:

M711LS43310120

Serial Numbers: 001-012, 013-025

Product: Implant Trial, 12 x 11 x 32mm x 12.5°, Tx

Model / REF:

LS-433-1112

Lot Numbers:

M711LS43311120

Serial Numbers: 001-012, 013-024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95185

Status: Active

Manufacturer: Innovasis, Inc

Sold By: Hospitals; Surgical sites; Orthopedic surgeons

Manufactured In: United States

Units Affected: 568 devices

Distributed To: Alabama, California, Colorado, Florida, Idaho, Michigan, South Dakota, Texas, Wisconsin