Recall archive / FDA device enforcement

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38... — FDA record Z-1418-2024

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. Source coverage and dates.

What the record says

Product: Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; 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: 66646 units
Agency-reported status: Ongoing
Source record identifier: Z-1418-2024

Open the official record

What the recall classes mean. 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 320-38-00, UDI/DI 10885862086655, Serial Numbers: 0983038, 0983044, 0983058, 1033005, 1034649, 0983051, 1032990, 1032983, 1032992, 1092744, 1092666, 1092747, 1030253, 1092653, 1092748, 0983081, 1032991, 1034629, 1034621, 1092680, 1030248, 1032986, 1032994, 1034627, 1092678, 1034630, 1034619, 0983085, 1032998, 0983043, 1092651, 1087764, 0983049, 1034639, 1030256, 0983074, 1034645, 1092655, 1092661, 1092669, 0983066, 1033002, 1034625, 1034623, 1034607, 1034609, 1034601, 1092636, 0983047, 1030255, 1032997, 1092771, 0983042, 1032995, 0983060, 0983075, 0983056, 0983063, 0983039, 0983079, 0983061, 1030257, 0983077, 0983037, 1030254, 1032987, 1033004, 1033000, 1032988, 0983045, 1033003, 1034605, 0983035, 1034648, 1092780, 1092769, 0983067, 0983068, 0983083, 0983048, 0983055, 1030249, 1030258, 1030250, 0983084, 1033006, 1092675, 1092649, 0983040, 0983070, 1032984, 0983053, 1032999, 1034650, 1092743, 1092741, 1092776, 1092767, 1034640, 1092751, 1034638, 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1463001, 1390457, 1392700, 1356301...

Label field

Details supplied by the agency

Lot, code or applicability

a) Item Number 320-38-00, UDI/DI 10885862086655, Serial Numbers: 0983038, 0983044, 0983058, 1033005, 1034649, 0983051, 1032990, 1032983, 1032992, 1092744, 1092666, 1092747, 1030253, 1092653, 1092748, 0983081, 1032991, 1034629, 1034621, 1092680, 1030248, 1032986, 1032994, 1034627, 1092678, 1034630, 1034619, 0983085, 1032998, 0983043, 1092651, 1087764, 0983049, 1034639, 1030256, 0983074, 1034645, 1092655, 1092661, 1092669, 0983066, 1033002, 1034625, 1034623, 1034607, 1034609, 1034601, 1092636, 0983047, 1030255, 1032997, 1092771, 0983042, 1032995, 0983060, 0983075, 0983056, 0983063, 0983039, 0983079, 0983061, 1030257, 0983077, 0983037, 1030254, 1032987, 1033004, 1033000, 1032988, 0983045, 1033003, 1034605, 0983035, 1034648, 1092780, 1092769, 0983067, 0983068, 0983083, 0983048, 0983055, 1030249, 1030258, 1030250, 0983084, 1033006, 1092675, 1092649, 0983040, 0983070, 1032984, 0983053, 1032999, 1034650, 1092743, 1092741, 1092776, 1092767, 1034640, 1092751, 1034638, 1092752, 0983086, 0983073, 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1356301...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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.

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 the record says

Lot and product identifiers

Distribution

Dates in the source

Related records