Exactech Vantage Mobile Bearing Tibial Inserts — Class II medical device recall Z-0588-2024
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-0588-2024 |
|---|---|
| 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 |
| Serial numbers | A658148, A688864, A688867, A688868, A688870, A688872, A688873, A688876, A688879, A688880, A688881, A688882 |
Product
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
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-0588-2024. 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.