Innovasis, Inc

Complete recall history across all FDA and CPSC categories — 6 total recalls

Innovasis, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by Innovasis, Inc

Date Product Reason Class
Aug 14, 2024 TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA P... Due to interfacing issues between the implant trial and inserter of the lumba... Class II
Apr 7, 2020 Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical... Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and V... Class II
Jan 8, 2018 Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletal... Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. Class II
May 5, 2017 Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*.... Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 ... Class II
Dec 7, 2015 Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod ... Innovasis recalled two lots of Excella II titanium rods which were packaged u... Class II
Jul 7, 2014 Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm... Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeli... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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