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Equinoxe

Model 320-38-00 · Exactech, Inc. · DI 10885862086655

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650

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)

InitiatedRecall #ClassStatusReasonLink basis
2025-08-15Z-2561-2025Class IIOpen, ClassifiedReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.code info di
2024-03-06Z-1418-2024Class IIOpen, ClassifiedThe 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).code info di
2023-11-21Z-0579-2024Class IIOpen, ClassifiedExactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.code info di

Adverse-event reports — MAUDE (274)

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.

Injury: 274

358102019-01: 3 reports for this device; peer average 1.88/device2019-02: 2 reports for this device; peer average 1.44/device2019-03: 0 reports for this device; peer average 1.27/device2019-04: 5 reports for this device; peer average 2.33/device2019-05: 4 reports for this device; peer average 2.31/device2019-06: 0 reports for this device; peer average 2/device2019-07: 2 reports for this device; peer average 1.71/device2019-08: 3 reports for this device; peer average 2.15/device2019-09: 3 reports for this device; peer average 1.69/device2019-10: 0 reports for this device; peer average 2.11/device2019-11: 0 reports for this device; peer average 1.36/device2019-12: 6 reports for this device; peer average 2.15/device2020-01: 0 reports for this device; peer average 1.79/device2020-02: 3 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.83/device2020-04: 3 reports for this device; peer average 1.38/device2020-05: 6 reports for this device; peer average 2.18/device2020-06: 8 reports for this device; peer average 2.32/device2020-07: 0 reports for this device; peer average 1.88/device2020-08: 0 reports for this device; peer average 2.32/device2020-09: 3 reports for this device; peer average 2.5/device2020-10: 9 reports for this device; peer average 2.65/device2020-11: 6 reports for this device; peer average 2.54/device2020-12: 4 reports for this device; peer average 1.92/device2021-01: 3 reports for this device; peer average 2/device2021-02: 5 reports for this device; peer average 1.52/device2021-03: 0 reports for this device; peer average 1.81/device2021-04: 9 reports for this device; peer average 1.97/device2021-05: 3 reports for this device; peer average 1.41/device2021-06: 3 reports for this device; peer average 1.41/device2021-07: 3 reports for this device; peer average 2.47/device2021-08: 3 reports for this device; peer average 2.5/device2021-09: 10 reports for this device; peer average 1.88/device2021-10: 3 reports for this device; peer average 2.21/device2021-11: 6 reports for this device; peer average 1.82/device2021-12: 0 reports for this device; peer average 2.3/device2022-01: 0 reports for this device; peer average 2.25/device2022-02: 0 reports for this device; peer average 2.64/device2022-03: 9 reports for this device; peer average 2.26/device2022-04: 1 reports for this device; peer average 2.19/device2022-05: 0 reports for this device; peer average 1.68/device2022-06: 5 reports for this device; peer average 2.69/device2022-07: 6 reports for this device; peer average 2.44/device2022-08: 3 reports for this device; peer average 2.08/device2022-09: 0 reports for this device; peer average 1.98/device2022-10: 2 reports for this device; peer average 1.64/device2022-11: 3 reports for this device; peer average 1.92/device2022-12: 7 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1.71/device2023-02: 0 reports for this device; peer average 1.67/device2023-03: 0 reports for this device; peer average 1.63/device2023-04: 2 reports for this device; peer average 1.66/device2023-05: 4 reports for this device; peer average 1.7/device2023-06: 3 reports for this device; peer average 1.75/device2023-07: 2 reports for this device; peer average 1.97/device2023-08: 6 reports for this device; peer average 1.7/device2023-09: 6 reports for this device; peer average 1.48/device2023-10: 2 reports for this device; peer average 1.44/device2023-11: 6 reports for this device; peer average 1.66/device2023-12: 2 reports for this device; peer average 1.37/device2024-01: 0 reports for this device; peer average 1.6/device2024-02: 0 reports for this device; peer average 2.17/device2024-03: 5 reports for this device; peer average 1.63/device2024-04: 2 reports for this device; peer average 1.89/device2024-05: 3 reports for this device; peer average 1.7/device2024-06: 4 reports for this device; peer average 1.88/device2024-07: 2 reports for this device; peer average 1.6/device2024-08: 4 reports for this device; peer average 1.62/device2024-09: 4 reports for this device; peer average 1.81/device2024-10: 2 reports for this device; peer average 1.74/device2024-11: 4 reports for this device; peer average 1.8/device2024-12: 5 reports for this device; peer average 1.89/device2025-01: 0 reports for this device; peer average 1.79/device2025-02: 7 reports for this device; peer average 1.81/device2025-03: 4 reports for this device; peer average 1.75/device2025-04: 2 reports for this device; peer average 2.24/device2025-05: 4 reports for this device; peer average 2.2/device2025-06: 4 reports for this device; peer average 1.84/device2025-07: 2 reports for this device; peer average 1.52/device2025-08: 9 reports for this device; peer average 1.95/device2025-09: 2 reports for this device; peer average 1.36/device2025-10: 1 reports for this device; peer average 1.54/device2025-11: 5 reports for this device; peer average 1.73/device2025-12: 2 reports for this device; peer average 2.04/device2026-01: 2 reports for this device; peer average 1.76/device2026-02: 0 reports for this device; peer average 1.47/device2026-03: 0 reports for this device; peer average 1.7/device2026-04: 2 reports for this device; peer average 1.72/device2026-05: 4 reports for this device; peer average 1.59/device2026-06: 2 reports for this device; peer average 1.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0131.88
2019-0221.44
2019-0301.27
2019-0452.33
2019-0542.31
2019-0602
2019-0721.71
2019-0832.15
2019-0931.69
2019-1002.11
2019-1101.36
2019-1262.15
2020-0101.79
2020-0232.04
2020-0301.83
2020-0431.38
2020-0562.18
2020-0682.32
2020-0701.88
2020-0802.32
2020-0932.5
2020-1092.65
2020-1162.54
2020-1241.92
2021-0132
2021-0251.52
2021-0301.81
2021-0491.97
2021-0531.41
2021-0631.41
2021-0732.47
2021-0832.5
2021-09101.88
2021-1032.21
2021-1161.82
2021-1202.3
2022-0102.25
2022-0202.64
2022-0392.26
2022-0412.19
2022-0501.68
2022-0652.69
2022-0762.44
2022-0832.08
2022-0901.98
2022-1021.64
2022-1131.92
2022-1272
2023-0101.71
2023-0201.67
2023-0301.63
2023-0421.66
2023-0541.7
2023-0631.75
2023-0721.97
2023-0861.7
2023-0961.48
2023-1021.44
2023-1161.66
2023-1221.37
2024-0101.6
2024-0202.17
2024-0351.63
2024-0421.89
2024-0531.7
2024-0641.88
2024-0721.6
2024-0841.62
2024-0941.81
2024-1021.74
2024-1141.8
2024-1251.89
2025-0101.79
2025-0271.81
2025-0341.75
2025-0422.24
2025-0542.2
2025-0641.84
2025-0721.52
2025-0891.95
2025-0921.36
2025-1011.54
2025-1151.73
2025-1222.04
2026-0121.76
2026-0201.47
2026-0301.7
2026-0421.72
2026-0541.59
2026-0621.56
This device (reports/month)Average device in KWT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K063569 — cited as predicate by K150458, K150568, K162325, K162567, K180632, K182536, K191561, K193098, K213546, K220847, K223833, K233482, K260583

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Exactech, Inc.

  • Warning Letter 2025-12-19 Exactech Sarasota, Inc.
  • Warning Letter 2024-01-19 Exactech, Inc.
  • Warning Letter 2024-01-19 Exactech, Inc.
  • OAI 2025-08-27 Exactech, Inc. · 9 citations
  • OAI 2025-08-27 Exactech, Inc. · 9 citations
  • OAI 2025-07-25 Exactech Sarasota, Inc. · 7 citations
  • VAI 2024-10-09 Exactech, Inc. · 0 citations
  • VAI 2024-10-09 Exactech, Inc. · 0 citations
  • OAI 2023-09-26 Exactech, Inc. · 2 citations
  • OAI 2023-09-26 Exactech, Inc. · 2 citations
  • VAI 2021-11-17 Exactech, Inc. · 4 citations
  • VAI 2021-11-17 Exactech, Inc. · 4 citations
  • VAI 2020-01-31 Exactech, Inc. · 7 citations
  • VAI 2020-01-31 Exactech, Inc. · 7 citations
  • VAI 2017-03-10 Exactech, Inc. · 7 citations
  • VAI 2017-03-10 Exactech, Inc. · 7 citations
  • NAI 2015-07-16 Exactech, Inc. · 0 citations
  • NAI 2015-07-16 Exactech, Inc. · 0 citations
  • NAI 2014-08-25 Exactech Sarasota, Inc. · 0 citations
  • NAI 2012-12-11 Exactech, Inc. · 0 citations
  • NAI 2012-12-11 Exactech, Inc. · 0 citations
  • VAI 2010-03-25 Exactech, Inc. · 0 citations
  • VAI 2010-03-25 Exactech, Inc. · 0 citations