OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial… — Class II medical device recall Z-0025-2022
Ongoing recall by Exactech, Inc., reported 2021-10-13, distributed nationwide. Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
| Recall number | Z-0025-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2021-08-30 |
| Classified | 2021-10-04 |
| Reported by FDA | 2021-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, DE, DZ, EC, ES, FR, GB, GH, GR, GT, IN, IT, JO, JP, KR, LB, LU, MX, MY, NL, NZ, PL, PT, RO, SG, TH, TN, TR, VE |
| Quantity | 33,103 devices |
| UPC / GTIN / UDI-DI | 10885862068842, 10885862068859, 10885862068866, 10885862068873, 10885862068880, 10885862068897, 10885862068903, 10885862068910, 10885862068927, 10885862068934, 10885862068941, 10885862068958, 10885862068965, 10885862068972, 10885862068989, 10885862068996, 10885862069009, 10885862069016, 10885862069023, 10885862069030 |
| Serial numbers | 044564, 0732151, 0732152, 0732153, 0732155, 0732156, 0732159, 0732160, 0732161, 0732162, 0732163, 0732164, 0732165, 0732167, 0732168, 0733164, 0733165, 0733166, 0733167, 0733168, 0733169, 0733170, 0733171, 0733172, 0733173 and 475 more |
Product
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Reason for recall
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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-0025-2022. 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.