Exactech, Inc. Recall: Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Pre
Exactech, Inc. Recall: Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Pre is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Exactech, Inc.; Product: Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature
| Recalling firm | Exactech, Inc. |
|---|---|
| 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 surgeon to be the preferred method of treatment. The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumera |
| Reason for recall | Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended . |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC. |
| Recall initiated | 20181205 |
| Recall number | Z-0958-2019 |
| Category | device |
| State | FL |
| Country | United States |
$29/mo
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