Reported Nov 4, 2020 · Terminated
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for…
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?
- Equinoxe Platform Fracture Stem, 6.5mm
- Right - Product UsageThe Equinoxe Platform Fracture Stem is indicated for cemented use only
- Lot codes and dates
- Catalog304-22-07
- Serial Range4971292-4971303
- Amount recalled
- 12 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 device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
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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