FDA recall Z-1149-2020

Product

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

AZ, CA, FL, TN Foreign: Italy

Key facts

Status

Terminated

Initiation date

2019-09-22

Report date

2020-02-19

Termination date

2020-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gieres, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2020