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Equinoxe
Model 320-15-10 · Exactech, Inc. · DI 10885862243997
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (3)
Initiated
Recall #
Class
Status
Reason
Link basis
2024-03-06
Z-1420-2024
Class II
Open, Classified
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).
k number procode
2024-03-06
Z-1421-2024
Class II
Open, Classified
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).
k number procode
2023-11-21
Z-0579-2024
Class II
Open, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
k number procode
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.83
2019-02
0
1.78
2019-03
0
1.68
2019-04
0
1.95
2019-05
0
2.13
2019-06
0
1.89
2019-07
0
1.69
2019-08
0
2.18
2019-09
0
1.67
2019-10
0
1.91
2019-11
0
1.68
2019-12
0
1.81
2020-01
0
1.94
2020-02
0
2.07
2020-03
0
2.16
2020-04
0
1.75
2020-05
0
1.71
2020-06
0
2.03
2020-07
0
2.21
2020-08
0
1.84
2020-09
0
2.01
2020-10
0
2.25
2020-11
0
1.95
2020-12
0
1.88
2021-01
0
2.19
2021-02
0
1.91
2021-03
0
2.09
2021-04
0
2.01
2021-05
0
1.92
2021-06
0
1.84
2021-07
0
2.11
2021-08
0
2.23
2021-09
0
1.96
2021-10
0
2.18
2021-11
0
2.07
2021-12
0
2.55
2022-01
0
2.6
2022-02
0
2.39
2022-03
0
2.46
2022-04
0
2.43
2022-05
0
2.06
2022-06
0
2.31
2022-07
0
2.22
2022-08
0
2.24
2022-09
0
2.03
2022-10
0
2.03
2022-11
0
2.13
2022-12
0
2.09
2023-01
0
1.83
2023-02
0
2
2023-03
0
1.98
2023-04
0
2.14
2023-05
0
2.06
2023-06
0
2.23
2023-07
0
2.09
2023-08
0
1.75
2023-09
0
1.57
2023-10
0
1.61
2023-11
0
1.69
2023-12
0
1.44
2024-01
0
1.85
2024-02
0
1.91
2024-03
0
1.71
2024-04
0
1.87
2024-05
0
1.72
2024-06
0
1.89
2024-07
0
1.63
2024-08
0
1.71
2024-09
0
1.75
2024-10
0
1.74
2024-11
0
1.67
2024-12
0
1.71
2025-01
0
1.75
2025-02
0
1.68
2025-03
0
1.9
2025-04
0
1.82
2025-05
0
1.9
2025-06
0
1.93
2025-07
0
1.74
2025-08
0
1.67
2025-09
0
1.49
2025-10
0
1.66
2025-11
0
1.74
2025-12
0
2.16
2026-01
0
1.9
2026-02
0
1.79
2026-03
0
1.79
2026-04
0
1.73
2026-05
0
1.76
2026-06
0
1.75
This device (reports/month)Average device in KWS, KWT, PHX (reports/device/month)