Blue Ortho TKA Pro Software Recalled for Incorrect Navigation Data
Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that results in incorrect data display during surgery, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Blue Ortho is recalling the Blue Ortho TKA Pro v2.1 software, which is installed on the Exactech GPS system and indicated for stereotaxic surgery in Knee Arthroplasty. The recall involves 7 units of the software.
The recall is being issued because the navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies, specifically wrong data being loaded. This issue could affect the accuracy of the surgical navigation system.
The affected software was distributed in Arizona, California, Florida, and Tennessee, as well as in Italy. Users of this software should contact Blue Ortho for further instructions on how to address the software inconsistency.
The recalled product
- Product
- Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
- Manufacturer
- Blue Ortho
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- TKA Pro v2.1 software
Distribution
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