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Terminated

Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

FDA Recall Z-1149-2020 · Posted None

Recalling FirmBlue Ortho
Recall StatusTerminated
Product CodeOLO
Date Initiated2019-09-22
Date Terminated2020-07-23
Product Quantity7 units

Reason for Recall

The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

Firm Action

Blue Ortho issued an Advisory Notice via email on September 22, 2019 stating the reason for recall, health risk and action to take: The issue happens only with the LPI instrumentation. There is no issue with the Truliant instrumentation. Therefore, Blue Ortho ask the user: To use the TKA Pro 2.1 software application with the Truliant instrumentation only, To NOT change the instrumentation once the protocol is started. Do not click on Change instrument nor Change to LPI.If the Truliant instrumentation is not available, the TKA Pro 2.1 software application must not be used. Blue Ortho will deliver a new software version correcting this issue.

Root Cause

Software design

Distribution Pattern

AZ, CA, FL, TN Foreign: Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152764EXACTECH GPSBlue Ortho · 2016-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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