Equinoxe Humeral Stem — Class II medical device recall Z-0884-2021
Ongoing recall by Exactech, Inc., reported 2021-01-27, distributed in CA, KS, OH. Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit,
| Recall number | Z-0884-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2020-11-09 |
| Classified | 2021-01-21 |
| Reported by FDA | 2021-01-27 |
| Distributed | CA, KS, OH |
| Countries outside the US | AU, DE |
| Quantity | 14 devices |
| UPC / GTIN / UDI-DI | 10885862079312 |
| Lot numbers | 49088921 |
| Serial numbers | 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, 6477407 |
| Model numbers | 300-01-11 |
Product
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Reason for recall
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
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-0884-2021. 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.