Reported Jul 5, 2023 · Ongoing
Exactech Ergo Impactor Handle, Catalog #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?
- Exactech Ergo Impactor Handle, Catalog #321-09-05.
- Lot codes and dates
- Catalog #321-09-05 -
- Lot numbers
147544002275151004275151005275151006314934001400107002and 400798002UDI-DI 10885862557674
- Updated data - 01/31/2025Additional Lot Numbers 401819005 401819007 401819008 404552002 405492002 405253003 406041001
- Amount recalled
- 784 devices
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
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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