Exactech equinoxe PLATFORM FRACTURE — Class II medical device recall Z-0872-2020
Terminated recall by Exactech, Inc., reported 2020-02-05. Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The transl
| Recall number | Z-0872-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-12-03 |
| Classified | 2020-01-28 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2022-10-11 |
| Countries outside the US | AT, AU, BR, CA, CN, CO, DE, ES, FR, GB, GT, IN, IT, JP, KR, LU, NL, SE, SG |
| Quantity | 2,910 devices |
| Reason classes | labeling, device malfunction |
| Model numbers | 304-22-07 |
Product
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Reason for recall
Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
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-0872-2020. 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.