Device product
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Z-0308-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 86590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
device-enforcement:Z-0308-2021
Official wording
Reason: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Code information: Catalog: 304-22-07; Serial Range: 4971292-4971303
Distribution pattern: 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.
Derived failure modes
-
Unknown
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.