CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
TKA Pro v2.1 recalled by Blue Ortho
Blue Ortho is recalling Blue Ortho TKA Pro v2.1, distributed in Arizona, California, Florida, Tennessee. The recall was initiated on 22 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1149-2020
- FDA event ID
- 84713
- Recalling firm
- Blue Ortho, Gieres
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2019
- FDA classified
- 11 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 22 Sep 2019 | Recall initiated by company | |
| 11 Feb 2020 | Classified by FDA | +142 days |
| 19 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Where it was distributed
AZ, CA, FL, TN Foreign: Italy
Questions about this recall
Is TKA Pro v2.1 recalled?
Yes. Blue Ortho recalled TKA Pro v2.1 on 22 Sep 2019. The recall is Class II and its status is Terminated. Recall number Z-1149-2020.
Why was it recalled?
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Which lots are affected?
TKA Pro v2.1 software
Where was it sold?
AZ, CA, FL, TN Foreign: Italy
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Blue Ortho
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Predict+ is a data-driven, clinical decision support tool recalled | Blue Ortho | Other | Nationwide |
| Device | CLASS II | Instructions For Use document of the GPS Trackers recalled by Blue Ortho | Blue Ortho | Sterility | 4 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |