Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Exactech, Inc.'s record for this product code
Recent MDR events
1,377 adverse event reports on file
- HUMERAL ADAPTER TRAY, +15Jul 31, 2026Injury1038671-2026-00962
- 145-DEG PE 46MM HUM LINER +2.5Jul 31, 2026Injury1038671-2026-00963
- RS GLENOID PLATE L POST AUG, 8 DEG, LEFTJul 29, 2026Injury1038671-2026-00954
- Equinoxe Primary Shoulder ComponentsJul 28, 2026Injury1038671-2026-00952
- EQUINOXE PRIMARY SHOULDER COMPONENTSJul 21, 2026Injury1038671-2026-00923
- EQUINOXE PRIMARY SHOULDER COMPONENTSJul 20, 2026Injury1038671-2026-00911
- EQUINOXE PRIMARY SHOULDER COMPONENTSJul 20, 2026Injury1038671-2026-00914
- EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MMJul 20, 2026Injury1038671-2026-00920
- EQUINOXE PRIMARY SHOULDER COMPONENTSJul 20, 2026Injury1038671-2026-00921
- EQUINOXE PRIMARY SHOULDER COMPONENTSJul 17, 2026Injury1038671-2026-00909
Recalls
23 recall events for this product code
- Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗ - Open, ClassifiedMar 29, 2024
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).
View FDA record ↗
510(k) clearances
8 clearances for this product code
- K212356Mar 4, 2022
Exactech® Equinoxe® Laser Cage Glenoid
- K140063Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
- K121220Nov 20, 2012
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
- K113309Dec 8, 2011
EXACTECH EQUINOXE CAGE GLENOIDS
- K111379Jun 8, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
- K103419Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
- K093430Sep 2, 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
- K042021Oct 26, 2004
EXACTECH EQUINOXE SHOULDER SYSTEM