The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3163-2024·Announced 2024-09-25

Innovasis spinal fusion devices recalled for implant-inserter interface defect

Innovasis is recalling TxHA PEEK and TxTiHA IBF intervertebral fusion devices due to interfacing issues between the implant and inserter that may prevent proper placement. The recall affects 568 devices distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving a manufacturing defect (interfacing issue) on a surgical implant that could prevent proper implantation. No injuries or deaths reported, but the defect poses a risk to patient outcomes in spinal fusion surgery.

Plain-English summary

Innovasis, Inc. is recalling the TxHA PEEK IBF and TxTiHA IBF System intervertebral body fusion devices (568 devices total). These are surgical implants intended to stabilize spinal segments, promote bone fusion, restrict motion, and reduce pain in patients requiring lumbar spine surgery.

The recall is due to interfacing issues between the implant trial components and the inserter tool. These interface problems could prevent proper alignment or insertion of the device during surgery, potentially affecting the success of the fusion procedure.

The affected devices were distributed nationwide to surgical centers in Alabama, California, Colorado, Florida, Idaho, Michigan, South Dakota, Texas, and Wisconsin. Only physicians trained in orthopedic surgery use these devices in hospital and surgical settings. Customers should immediately quarantine and cease use of affected inventory and contact Innovasis for instructions on return or replacement.

The recalled product

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…
Manufacturer
Innovasis, Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
568

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Part Number and Description: LS-397-0705 Implant Trial
  • 10 x 7 x 28mm x 5¿
  • 10 x 8 x 28mm x 5¿
  • 10 x 9 x 28mm x 5¿
  • 10 x 10 x 28mm x 5¿
  • 10 x 11 x 28mm x 5¿
  • 10 x 08 x 28mm x 10¿
  • 10 x 09 x 28mm x 10¿
  • 10 x 10 x 28mm x 10¿
  • 10 x 11 x 28mm x 10¿
  • 10 x 09 x 28mm x 12.5¿
  • 10 x 10 x 28mm x 12.5¿
  • 10 x 11 x 28mm x 12.5¿
  • 12 x 8 x 32mm x 5¿
  • 12 x 9 x 32mm x 5¿
  • 12 x 10 x 32mm x 5¿
  • 12 x 11 x 32mm x 5¿
  • 12 x 09 x 32mm x 10¿
  • 12 x 10 x 32mm x 10¿
  • 12 x 11 x 32mm x 10¿

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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