FDASeptember 22, 2019device
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
What to do
FDA enforcement status: Terminated
Brands named
blue orthoblue
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCBlue Wave Recalls Above-Ground Pools 48 Inches and Taller Due to Drowning Hazard2025-12-18
- FDABlue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 1987156843222025-10-30
- FDAChocolate Chip Cookie Dough ice cream cartons with a Moo-llennium Crunch lid. Packaging contains Moo-llennium crunch. Packaged in half gallon cartons (1.89 L)2025-08-21
- FDAChemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.2025-07-29
- FDAVITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.2025-07-29
- FDAVITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;2025-07-09
- FDAVITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.2025-06-12
- FDABrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/...2025-06-10
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →