Home / Recalls / Blue Ortho / Z-1149-2020

Z-1149-2020 Class II Terminated

Recalled by Blue Ortho — Gieres

FDA device recall Z-1149-2020 was initiated by Blue Ortho on Sep 22, 2019 and is designated Class II. Reason for recall: The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded). The recall status is terminated (terminated Jul 23, 2020). Affected quantity: 7 units.

Recall details

Product Type: Devices
Report Date: Feb 19, 2020
Initiation Date: Sep 22, 2019
Termination Date: Jul 23, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7 units

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

Reason for recall

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

Distribution pattern

AZ, CA, FL, TN Foreign: Italy

Code information

TKA Pro v2.1 software

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1149-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.