Reported Feb 19, 2020 · Terminated
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee…
Blue Ortho
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Blue Ortho · 6 Allee De Bethleem · Gieres · N/A
Is this the product you have?
- Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery
- in Knee Arthroplasty Catalog ReferenceL00002
- Lot codes and dates
- TKA Pro v2.1 software
- Amount recalled
- 7 units
Where it was sold
Why it was recalled
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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