FDA Device recall Z-1149-2020
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Refer…
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Refer… by Blue Ortho, citing the navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1149-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-22 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Blue Ortho |
| Distribution | AZ, CA, FL, TN |
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
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Identifiers
| code_info | TKA Pro v2.1 software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1149-2020%22
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