Innovasis Recalls

4 recalls on record in the United States

medical: 4
medical Class II
2018-02-28

Innovasis, Inc recalls Excella II Polyaxial Pedicle Screw used as a pedicle screw s

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

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medical Class II
2017-05-31

Innovasis, Inc recalls Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22

Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).

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medical Class II
2024-09-25

Innovasis, Inc recalls TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The

Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.

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medical Class II
2020-05-27

Innovasis, Inc recalls Oryx Cervical Screw Caddy, Model Number BTA-172, as part of

Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.

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