FDA Device recall Z-0308-2021
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only by Exactech, citing the device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0308-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-25 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Exactech |
| Distribution | US |
Product
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Reason
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Identifiers
| code_info | Catalog: 304-22-07; Serial Range: 4971292-4971303 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0308-2021%22
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