Recall Z-1149-2020— Blue Ortho
Class II · Terminated
Class II FDA medical device recall by Blue Ortho, initiated 2019-09-22, terminated 2020-07-23. It names one FDA 510(k) clearance: K152764. 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)..
- Recalling firm
- Blue Ortho
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-22
- Terminated
- 2020-07-23
- Firm location
- Gieres, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.