--- title: "Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, S... — FDA record Z-1405-2024 | Is It on Recall" description: "The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were pack" url: https://isitonrecall.com/recall/fda-device-z-1405-2024-exactech-equinoxe-glenoid-keeled-cemented-47-50-53-head-beta-curvature-sizes-a-small-item-number-314/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b... — FDA record Z-1405-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Mar 6, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, 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). - **Classification**: Class II - **Recalling firm**: Exactech, Inc. - **Quantity**: 6840 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1405-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1405-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | a) Item Number 314-02-12, UDI/DI 10885862084507, Serial Numbers: 0790902, 0790901, 0790903, 0790904, 0790907, 0790908, 0790910, 0790919, 0790899, 0790912, 0797553, 0790917, 0797597, 0797605, 0797554, 0797582, 0790914, 0797567, 0797583, 0790900, 0797537, 0797606, 0790918, 0797559, 1340014, 1356689, 1356703, 1361002, 1361004, 1388246, 0797538, 0797563, 0797603, 0797573, 0797560, 0797572, 0797578, 0790898, 0797550, 0797574, 0790893, 1340017, 1340012, 1425621, 1388234, 1388236, 1425335, 1425344, 1360995, 1535521, 1356704, 1425620, 1340013, 1361005, 1425347, 1425626, 1425636, 1425338, 1425629, 1591628, 1591621, 1425334, 1360998, 1388247, 1425619, 1425634, 0797602, 0797552, 0797540, 0797587, 0790897, 1594675, 1356696, 1535516, 1591609, 1594683, 1591634, 1535523, 1594687, 1361008, 1340015, 1591616, 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6060057, 6060062, 6060039, 5925069, 6060249, 6060251, 6060255, 6060259, 5963038, 5963039, 5963048, 5963052, 6060079, 6060097, 5963047, 5074742, 6060265, 6060058, 6060044, 6060096, 6060078, 6060108, 6060254, 4903108, 5963037, 6060048, 6751144, 6751149, 6751150, 6751152, 6931677, 6931679, 6931683, 6931684, 6931685, 6751139, 6773175, 6751136, 6751155, 6060088, 6060017, 6773170, 6880994, 6880996, 6881000, 6751113, 6060252, 6060086, 7023040, 7023036, 7023042, 7023050, 7023066, 7023031, 7023033, 7023061, 7023062, 7023065, 7023069, 7023054, 6883218, 6773158; b) Item Number 314-02-13, UDI/DI 10885862084514, Serial Numbers: 0767969, 0767996, 0746108, 0767974, 0767959, 0767995, 0746113, 0767961, 0746119, 0767956, 0746120, 0746111, 0767976, 0767960, 0746122, 0767935, 0767983, 0746121, 0767993, 0767937, 0767955, 0746128, 0767977, 0767951, 0767944, 0767924, 0775207, 0774857, 0767923, 0774855, 0746125, 0768254, 0768168, 0767972, 0768202, 0767934, 0768169, 0767952, 0767967, 0768218, 0767982, 0768167, 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1285425, 1285375, 1496963, 1424838, 1362314, 1285411, 1285422, 1424863, 1457309, 1477972, 1496975, 1362311, 1246508, 1424865, 1362331, 1487805, 1285449, 1285432, 1285403, 1362325, 1285387, 1362316, 15227... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1405-2024%22). Match all identifying details in the current notice. A brand name alone is not enough. ## 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 States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 10, 2024 - **Recall initiation date**: Mar 6, 2024 - **Center classification date**: Mar 29, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1405-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Exactech, Inc. records](https://isitonrecall.com/brand/exactech-inc/)