FDA Device recall Z-1406-2024
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22,…
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22,… by Exactech, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1406-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-06 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Exactech |
| Distribution | US |
Product
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
Reason
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).
Identifiers
| code_info | a) Item Number 314-02-22, UDI/DI 10885862175052, Serial Numbers: 1984576, 1984575, 2090821, 1984570, 1984581, 1984569,…a) Item Number 314-02-22, UDI/DI 10885862175052, Serial Numbers: 1984576, 1984575, 2090821, 1984570, 1984581, 1984569, 2090824, 2093611, 2090832, 2090825, 2379003, 2090861, 2090820, 1984577, 2090843, 2378999, 2379029, 2425682, 2378998, 2090854, 2425684, 2093636, 2090855, 2093634, 2425676, 1984573, 2485867, 2379017, 2090842, 2640254, 2640262, 2640255, 2754817, 2093618, 2379019, 2090826, 2640241, 2654891, 2093613, 2093621, 2654890, 2485860, 2425689, 2090863, 2425683, 2654887, 2628323, 2640277, 2951278, 2961486, 2090862, 2090850, 2640252, 2640279, 2654888, 2654892, 2654894, 2379025, 2640261, 2754818, 3600551, 3600548, 3600552, 3600562, 3600553, 3600561, 3600565, 3600560, 3600550, 3600559, 2090852, 2654893, 2425667, 2145999, 2425669, 2594873, 2640268, 2628315, 2640280, 2754815, 2983602, 4523829, 4523835, 3936374, 3570106, 3570101, 3570098, 3936367, 2640271, 3941936, 3600547, 4431925, 4987572, 4987573, 4925598, 2640257, 4497767, 3600546, 3936376, 3600556, 4459029, 3570097, 4459036, 5304678 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1406-2024%22
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