Exactech Equinoxe GLENOID — Class II medical device recall Z-1405-2024
Ongoing recall by Exactech, Inc., reported 2024-04-10, distributed nationwide. The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the e
| Recall number | Z-1405-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2024-03-06 |
| Classified | 2024-03-29 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CN, CO, DE, ES, FR, GB, GR, GT, IN, IT, JP, KR, LU, MY, NL, NZ, PT, SE, SG, TH, ZA |
| Quantity | 6,840 units |
| UPC / GTIN / UDI-DI | 10885862084507, 10885862084514, 10885862084521, 10885862084538 |
| Serial numbers | 0746106, 0746107, 0746108, 0746109, 0746110, 0746111, 0746112, 0746113, 0746117, 0746118, 0746119, 0746120, 0746121, 0746122, 0746125, 0746128, 0767922, 0767923, 0767924, 0767925, 0767926, 0767930, 0767931, 0767932, 0767933 and 475 more |
| Model numbers | 314-02-12, 314-02-13, 314-02-14, 314-02-15 |
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
Reason for recall
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
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-1405-2024. 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.