Exactech Equinoxe Reverse Shoulder System — Class II medical device recall Z-0579-2024
Ongoing recall by Exactech, Inc., reported 2023-12-27, distributed in AR, FL, GA, IL, IN, KY, MD, ME…. Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
| Recall number | Z-0579-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2023-11-21 |
| Classified | 2023-12-19 |
| Reported by FDA | 2023-12-27 |
| Distributed | AR, FL, GA, IL, IN, KY, MD, ME, MN, NH, NV, NY, SC, TN, TX, VA |
| Countries outside the US | AU, BR, CL, DE, ES, FR, GB, GT, IT, JP, KR, SI |
| UPC / GTIN / UDI-DI | 10885862086617, 10885862086624, 10885862086631, 10885862086648, 10885862086655, 10885862086686, 10885862086693, 10885862086716, 10885862086723, 10885862086754, 10885862086761, 10885862535030, 10885862535054 |
| Serial numbers | A638847, A638848, A638849, A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989, A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A641190, A641191, A641194 and 257 more |
Product
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13
Reason for recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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-0579-2024. 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.