Excella II Rod Cat — Class II medical device recall Z-0662-2016
Terminated recall by Innovasis, Inc, reported 2016-01-27, distributed in CA, KS, OH, TX. Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
| Recall number | Z-0662-2016 |
|---|---|
| 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 | 2015-12-07 |
| Classified | 2016-01-19 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-04-07 |
| Distributed | CA, KS, OH, TX |
| Reason classes | labeling |
| Lot numbers | 1502, SR55100 |
| Model numbers | 100, 110, 5.5, 55100, 55110, SR55110 |
Product
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.
Reason for recall
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
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-0662-2016. 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.