courtlistener_docket
1 records
Innovasis Inc v. English
2026-06-01
Federal docket 2:26-cv-00511 (utd); matched party 'Innovasis Inc'
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fda
6 records
FDA Device Recall: TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK
2024-09-25
Class II — Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
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FDA Recall: Innovasis, Inc — Class II
20180228
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. | Product: Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is
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FDA Device Recall: Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally
2018-02-28
Class II — Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
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FDA Device Recall: Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. P
2017-05-31
Class II — Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
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FDA Device Recall: Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat
2016-01-27
Class II — Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
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FDA Device Recall: Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x
2014-07-23
Class II — Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
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