FDA Device recall Z-1402-2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02 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-1402-2024 |
| 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,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, 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 314-01-02, UDI/DI 10885862084408, Serial Numbers: 0745683, 0747928, 0745666, 0747961, 0747950, 0747985,…a) Item Number 314-01-02, UDI/DI 10885862084408, Serial Numbers: 0745683, 0747928, 0745666, 0747961, 0747950, 0747985, 0747941, 0747948, 0745671, 0745675, 0747921, 0745670, 0747929, 0747944, 0747995, 0748000, 0745681, 0747932, 0747935, 0747942, 0745684, 0747949, 0747981, 0747991, 0747958, 0802455, 0745677, 0747970, 0802458, 0747977, 0747939, 0745680, 0802390, 0747976, 0745673, 0747952, 0747923, 0747988, 0747980, 0802385, 0802381, 0747982, 0747959, 0747963, 0747930, 0747975, 0745682, 0747938, 0747962, 0802387, 0745674, 0747927, 0802395, 0745669, 0747957, 0747996, 0747974, 0747971, 0747990, 0747993, 0747969, 0802456, 0802457, 0802446, 0802414, 0747992, 0802463, 0802479, 0802410, 0802433, 0802418, 0802437, 0802376, 0745679, 0745665, 0747920, 0802404, 0802428, 0802478, 0748001, 0802400, 0802384, 0747968, 0747973, 0802378, 0802435, 0802477, 0747999, 0747994, 0747933, 0802443, 0802454, 0747964, 0802392, 0802417, 0802460, 0802429, 0802373, 0802452, 0745667, 0802405, 0747925, 0747953, 0802396 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Exactech
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Des…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1402-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.