Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Reported: November 4, 2020 Initiated: September 25, 2020 #Z-0307-2021
Product Description
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Reason for Recall
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 25 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.. Recalled by Exactech, Inc.. Units affected: 25 devices.
Why was this product recalled? ▼
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0307-2021.
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