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Equinoxe

Model 321-01-31 · Exactech, Inc. · DI 10885862201669

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 (0)

No recalls linked in the loaded window.

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.

11232019-01: 0 reports for this device; peer average 1.88/device2019-02: 0 reports for this device; peer average 1.44/device2019-03: 0 reports for this device; peer average 1.27/device2019-04: 0 reports for this device; peer average 2.33/device2019-05: 0 reports for this device; peer average 2.31/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1.71/device2019-08: 0 reports for this device; peer average 2.15/device2019-09: 0 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: 0 reports for this device; peer average 2.15/device2020-01: 0 reports for this device; peer average 1.79/device2020-02: 0 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.83/device2020-04: 0 reports for this device; peer average 1.38/device2020-05: 0 reports for this device; peer average 2.18/device2020-06: 0 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: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 2.65/device2020-11: 0 reports for this device; peer average 2.54/device2020-12: 0 reports for this device; peer average 1.92/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1.52/device2021-03: 0 reports for this device; peer average 1.81/device2021-04: 0 reports for this device; peer average 1.97/device2021-05: 0 reports for this device; peer average 1.41/device2021-06: 0 reports for this device; peer average 1.41/device2021-07: 0 reports for this device; peer average 2.47/device2021-08: 0 reports for this device; peer average 2.5/device2021-09: 0 reports for this device; peer average 1.88/device2021-10: 0 reports for this device; peer average 2.21/device2021-11: 0 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: 0 reports for this device; peer average 2.26/device2022-04: 0 reports for this device; peer average 2.19/device2022-05: 0 reports for this device; peer average 1.68/device2022-06: 0 reports for this device; peer average 2.69/device2022-07: 0 reports for this device; peer average 2.44/device2022-08: 0 reports for this device; peer average 2.08/device2022-09: 0 reports for this device; peer average 1.98/device2022-10: 0 reports for this device; peer average 1.64/device2022-11: 0 reports for this device; peer average 1.92/device2022-12: 0 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: 0 reports for this device; peer average 1.66/device2023-05: 0 reports for this device; peer average 1.7/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 1.97/device2023-08: 0 reports for this device; peer average 1.7/device2023-09: 0 reports for this device; peer average 1.48/device2023-10: 0 reports for this device; peer average 1.44/device2023-11: 0 reports for this device; peer average 1.66/device2023-12: 0 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: 0 reports for this device; peer average 1.63/device2024-04: 0 reports for this device; peer average 1.89/device2024-05: 0 reports for this device; peer average 1.7/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1.62/device2024-09: 0 reports for this device; peer average 1.81/device2024-10: 0 reports for this device; peer average 1.74/device2024-11: 0 reports for this device; peer average 1.8/device2024-12: 0 reports for this device; peer average 1.89/device2025-01: 0 reports for this device; peer average 1.79/device2025-02: 0 reports for this device; peer average 1.81/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 2.24/device2025-05: 0 reports for this device; peer average 2.2/device2025-06: 0 reports for this device; peer average 1.84/device2025-07: 0 reports for this device; peer average 1.52/device2025-08: 0 reports for this device; peer average 1.95/device2025-09: 0 reports for this device; peer average 1.36/device2025-10: 0 reports for this device; peer average 1.54/device2025-11: 0 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 2.04/device2026-01: 0 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: 0 reports for this device; peer average 1.72/device2026-05: 0 reports for this device; peer average 1.59/device2026-06: 0 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)
2019-0101.88
2019-0201.44
2019-0301.27
2019-0402.33
2019-0502.31
2019-0602
2019-0701.71
2019-0802.15
2019-0901.69
2019-1002.11
2019-1101.36
2019-1202.15
2020-0101.79
2020-0202.04
2020-0301.83
2020-0401.38
2020-0502.18
2020-0602.32
2020-0701.88
2020-0802.32
2020-0902.5
2020-1002.65
2020-1102.54
2020-1201.92
2021-0102
2021-0201.52
2021-0301.81
2021-0401.97
2021-0501.41
2021-0601.41
2021-0702.47
2021-0802.5
2021-0901.88
2021-1002.21
2021-1101.82
2021-1202.3
2022-0102.25
2022-0202.64
2022-0302.26
2022-0402.19
2022-0501.68
2022-0602.69
2022-0702.44
2022-0802.08
2022-0901.98
2022-1001.64
2022-1101.92
2022-1202
2023-0101.71
2023-0201.67
2023-0301.63
2023-0401.66
2023-0501.7
2023-0601.75
2023-0701.97
2023-0801.7
2023-0901.48
2023-1001.44
2023-1101.66
2023-1201.37
2024-0101.6
2024-0202.17
2024-0301.63
2024-0401.89
2024-0501.7
2024-0601.88
2024-0701.6
2024-0801.62
2024-0901.81
2024-1001.74
2024-1101.8
2024-1201.89
2025-0101.79
2025-0201.81
2025-0301.75
2025-0402.24
2025-0502.2
2025-0601.84
2025-0701.52
2025-0801.95
2025-0901.36
2025-1001.54
2025-1101.73
2025-1202.04
2026-0101.76
2026-0201.47
2026-0301.7
2026-0401.72
2026-0501.59
2026-0601.56
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