Z-1149-2020 Class II Terminated
FDA device recall Z-1149-2020 was initiated by Blue Ortho on September 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 July 23, 2020). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- September 22, 2019
- Termination Date
- July 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