Reported Jan 27, 2021 · Ongoing
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
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 Humeral Stem, Primary, Press Fit, 11mm
- Lot codes and dates
- Catalog Number300-01-11
- Packaging Lot49088921
- UDI10885862079312
- Serial Numbers
6477393647739464773956477397647739864773996477400647740164774026477403647740464774056477406and 6477407
- Amount recalled
- 14 devices
Where it was sold
Why it was recalled
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
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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