FDA Device recall Z-0414-2018
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with…
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with… by Exactech, citing potentially mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0414-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-31 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | AL, AZ, CA, CO, FL, GA, ME, MN, OH, OK, PR, SC, TN, VA, WI |
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.
Reason
Potentially mislabeled.
Identifiers
| code_info | Catalog #: 314-13-03 Serial Range: 5013050 - 5013079 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2018%22
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