Blue Ortho: Medical Device Recall in 2020 - (Recall #: Z-1149-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 22, 2019

Date Posted: February 19, 2020

Recall Number: Z-1149-2020

Event ID: 84713

Reason for Recall:

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

Status: Terminated

Product Quantity: 7 units

Code Information:

TKA Pro v2.1 software

Distribution Pattern:

AZ, CA, FL, TN Foreign: Italy

Voluntary or Mandated:

Voluntary: Firm initiated