Device product
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Z-1149-2020
Product summary
- Firm
- Blue Ortho
- Event
- Event 84713
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1149-2020
Official wording
Reason: The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Code information: TKA Pro v2.1 software
Distribution pattern: AZ, CA, FL, TN Foreign: Italy
Derived failure modes
-
Device software or design
incorrect due to software