Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Reported: January 27, 2021 Initiated: November 9, 2020 #Z-0884-2021
Product Description
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Reason for Recall
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 14 devices
- Distribution
- Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Equinoxe Humeral Stem, Primary, Press Fit, 11mm. Recalled by Exactech, Inc.. Units affected: 14 devices.
Why was this product recalled? ▼
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2021. Severity: Moderate. Recall number: Z-0884-2021.
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