FDA Medical Device Recalls (openFDA)
Blue Ortho: Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
- Recall number
- Z-1149-2020
- 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
- Status
- Terminated
- Initiated
- 2019-09-22
- Posted
- not on file
- Terminated
- 2020-07-23
- Reason
- The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
- 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
- 7 units
- Distribution
- AZ, CA, FL, TN Foreign: Italy
- Lot, serial or model codes
- TKA Pro v2.1 software
- 510(k) numbers
- ["K152764"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3008027912
- Firm city
- Gieres
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28