Exactech Optetrak Knee System — Class II medical device recall Z-0582-2024
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-0582-2024 |
|---|---|
| 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 | 10885862039576, 10885862039583, 10885862039590, 10885862039606, 10885862039613, 10885862039620, 10885862039651, 10885862048165, 10885862048288, 10885862054289, 10885862054340, 10885862314277, 10885862314284, 10885862314291 |
| Serial numbers | A655589, A655621, A655637, A655640, A655641, A655656, A655657, A655659, A655667, A655676, A655685, A655691, A656015, A656020, A656022, A656026, A656030, A656031, A656032, A656033, A656035, A656038, A661377, A661380, A661381 and 83 more |
Product
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
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-0582-2024. 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.