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Innovasis, Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw SystemClass IIMay 22, 2026Pedicle screw system intended to provide immobilization/stab
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fuClass IIAug 14, 2024Due to interfacing issues between the implant trial and inse

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