FDA Device recall Z-1425-2024

Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13

FDA Device
Class II
ongoing
Published 2024-04-10

On 2024-04-10 the FDA classified a Class II recall of Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13 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-1425-2024
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 REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; 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 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091,… a) Item number 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091, 1018097, 1018084, 0984530, 0984547, 0984529, 0984532, 1332742, 1361390, 1545622, 1545624, 1361388, 1466508, 1466510, 1466513, 1466514, 1469127, 1466511, 1469130, 1683551, 1683520, 1683540, 1683541, 1683545, 1683548, 1683552, 1683554, 1683557, 1683515, 1332737, 1469126, 2010727, 1683514, 1683532, 1683529, 1683536, 2118729, 2118731, 2104263, 2118733, 2118732, 0984535, 1332736, 1361392, 1683527, 2010723, 1683558, 2010721, 1683523, 1683528, 2194597, 2265086, 2296247, 2296249, 2104265, 2265088, 2394874, 2394872, 2104261, 2151089, 2427260, 2427269, 2296245, 2532045, 2394871, 2296262, 2532055, 2151096, 2265081, 2532038, 2532065, 2532066, 2532061, 1466512, 1683556, 1683531, 2194603, 2427272, 2151091, 2532054, 2532053, 2532037, 2532044, 3533621, 2847727, 2847735, 1683544, 1683524, 2118730, 2104264, 2532058, 2194598, 2265090, 2532059, 2532052, 2532048, 2532035, 2532057, 2532060

code_info

a) Item number 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091,…

a) Item number 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091, 1018097, 1018084, 0984530, 0984547, 0984529, 0984532, 1332742, 1361390, 1545622, 1545624, 1361388, 1466508, 1466510, 1466513, 1466514, 1469127, 1466511, 1469130, 1683551, 1683520, 1683540, 1683541, 1683545, 1683548, 1683552, 1683554, 1683557, 1683515, 1332737, 1469126, 2010727, 1683514, 1683532, 1683529, 1683536, 2118729, 2118731, 2104263, 2118733, 2118732, 0984535, 1332736, 1361392, 1683527, 2010723, 1683558, 2010721, 1683523, 1683528, 2194597, 2265086, 2296247, 2296249, 2104265, 2265088, 2394874, 2394872, 2104261, 2151089, 2427260, 2427269, 2296245, 2532045, 2394871, 2296262, 2532055, 2151096, 2265081, 2532038, 2532065, 2532066, 2532061, 1466512, 1683556, 1683531, 2194603, 2427272, 2151091, 2532054, 2532053, 2532037, 2532044, 3533621, 2847727, 2847735, 1683544, 1683524, 2118730, 2104264, 2532058, 2194598, 2265090, 2532059, 2532052, 2532048, 2532035, 2532057, 2532060

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-1425-2024%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.