Excella II Polyaxial Pedicle Screw used as a pedicle screw system in… — Class II medical device recall Z-0644-2018
Terminated recall by Innovasis, Inc, reported 2018-02-28. Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
| Recall number | Z-0644-2018 |
|---|---|
| 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 | 2018-01-08 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-02-27 |
| Quantity | 1,010 parts |
| Reason classes | device malfunction |
| Lot numbers | 1101, 1201 |
| Model numbers | E28540, E28545, E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 |
Product
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
Reason for recall
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
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-0644-2018. 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.