Reported Mar 18, 2026 · Ongoing
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Brand NameEquinoxe
- Ergo Product NameErgo Modular
- Impactor Handle Model/Catalog Number321-09-05
- Lot codes and dates
- Lot CodePart
- Number321-09-05
- UDI-DI10885862557674
- Lot NumberAll (Please refer to Attachment 1 - Product Information Spreadsheet for details)
- Amount recalled
- 120 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Impactor handle may be missing cross-pin
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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