Exactech, Inc. Recall: Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o,
Exactech, Inc. Recall: Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Exactech, Inc.; Product: Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item N
| Recalling firm | Exactech, Inc. |
|---|---|
| Product | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty |
| Reason for recall | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand |
| Recall initiated | 20240306 |
| Recall number | Z-1407-2024 |
| Category | device |
| State | FL |
| Country | United States |
$29/mo
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