United StatesExactech is recalling the Equinoxe Ergo Ergo Modular Impactor Handle (Model/Catalog 321-09-05, UDI‑DI 10885862557674, All Lots) and the Equinoxe Core Instrument Kit (KIT‑311X, UDI‑DI 10885862559166, All Lots); the recall covers 120 handles and 596 kits. The products were recalled because the impactor handle may be missing the cross‑pin, which could create a hazard.
What's being recalled
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Recalling firm: Exactech, Inc., Gainesville, FL, United States.
How to identify it
Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details) All Lots/ UDI-DI: 10885862559166
The hazard
Impactor handle may be missing cross-pin
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
US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
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)