Z-1149-2020Class II

Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in...

Name: Z-1149-2020 Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in...
Creator: Blue Ortho
Published: 2019-09-22
License: https://open.fda.gov/license/

Blue Ortho / initiated 2019-09-22 / Terminated / root cause: software

FDA source

Blue Ortho began a recall of Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002 on 2019-09-22. FDA classified it as Class II and gives the reason as "The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1149-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-22
Posted: 2020-02-11
Terminated: 2020-07-23
Recalling firm: Blue Ortho
Product: Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 7 units
Distribution: AZ, CA, FL, TN Foreign: Italy
Product codes and lots: TKA Pro v2.1 software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1149-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-11

Product code OLO

K152764Class IIExactech GpsBlue Ortho / cleared 2016-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)