FDA-Device2024-09-25Class II
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 fu
Innovasis, Inc
Hazard
Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Sold states
U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
Affected count
568 devices
Manufactured in
614 E 3900 S, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3163-2024Don't want to check this manually?
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