Blue Ortho TKA Pro v2 — Class II medical device recall Z-1149-2020
Terminated recall by Blue Ortho, reported 2020-02-19, distributed in AZ, CA, FL, TN. The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencie
| Recall number | Z-1149-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Ortho, Gieres, France |
| Recall initiated | 2019-09-22 |
| Classified | 2020-02-11 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-07-23 |
| Distributed | AZ, CA, FL, TN |
| Countries outside the US | IT |
| Quantity | 7 units |
| Reason classes | software |
Product
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Reason for recall
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
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-1149-2020. 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.