Excella II Standard Pedicle Screw — Class II medical device recall Z-2067-2014
Terminated recall by Innovasis, Inc, reported 2014-07-23, distributed nationwide. Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number
| Recall number | Z-2067-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innovasis, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2014-07-07 |
| Classified | 2014-07-16 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2014-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 32 |
| Reason classes | labeling |
| Lot numbers | 1301, E2S47535 |
| Model numbers | 4.75, E2S47525, E2S47535 |
Product
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Reason for recall
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2067-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.