Device product
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Z-0414-2018
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 78903
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30
- Official record key
device-enforcement:Z-0414-2018
Official wording
Reason: Potentially mislabeled.
Code information: Catalog #: 314-13-03 Serial Range: 5013050 - 5013079
Distribution pattern: Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
Derived failure modes
-
Labeling or packaging
mislabeled