Device recall
Z-0958-2019: Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-0958-2019 |
|---|---|
| Recall event | 82025 |
| Product | Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplasty is determined by the… |
| Product code | PHX |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2021 |
| 510(k) numbers | K162726 |
| FEI number | 1038671 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database