United StatesExactech is recalling three Equinoxe Ergo surgical items: Adjustable Angle rTSA Reamer, 42mm (part 321-59-42, UDI-DI 10885862593009, lot 410398-013), Adjustable Angle rTSA Reamer, 46mm (part 321-59-46, UDI 10885862605535, lot 410398-014), and Ergo Augments Pilot Tip Converter (part 301-11-11, UDI 10885862592934, lot 410413-001). They were distributed before required design updates and performance testing were completed and may not conform to design and performance criteria.
What's being recalled
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
Recalling firm: Exactech, Inc., Gainesville, FL, United States.
How to identify it
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013 Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014 Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
The hazard
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.: SC O.U.S.: N/A
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)