FDA Device recall Z-0884-2021
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
- FDA Device
- Class II
- ongoing
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of Equinoxe Humeral Stem, Primary, Press Fit, 11mm by Exactech, citing potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0884-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-09 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | CA, KS, OH |
Product
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Reason
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Identifiers
| code_info | Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 647…Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0884-2021%22
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