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Equinoxe

Model 315-27-24 · Exactech, Inc. · DI 10885862085542

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

UDILibrary device dossier · generated 2026-09-07 · 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.

11222019-01: 0 reports for this device; peer average 1.68/device2019-02: 0 reports for this device; peer average 1.59/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 1.52/device2019-05: 0 reports for this device; peer average 1.76/device2019-06: 0 reports for this device; peer average 1.87/device2019-07: 0 reports for this device; peer average 1.41/device2019-08: 0 reports for this device; peer average 1.97/device2019-09: 0 reports for this device; peer average 1.48/device2019-10: 0 reports for this device; peer average 1.8/device2019-11: 0 reports for this device; peer average 1.62/device2019-12: 0 reports for this device; peer average 1.74/device2020-01: 0 reports for this device; peer average 1.89/device2020-02: 0 reports for this device; peer average 2.15/device2020-03: 0 reports for this device; peer average 1.76/device2020-04: 0 reports for this device; peer average 1.72/device2020-05: 0 reports for this device; peer average 1.43/device2020-06: 0 reports for this device; peer average 1.8/device2020-07: 0 reports for this device; peer average 1.91/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 1.92/device2020-10: 0 reports for this device; peer average 2.1/device2020-11: 0 reports for this device; peer average 1.85/device2020-12: 0 reports for this device; peer average 1.82/device2021-01: 0 reports for this device; peer average 1.95/device2021-02: 0 reports for this device; peer average 1.82/device2021-03: 0 reports for this device; peer average 1.98/device2021-04: 0 reports for this device; peer average 1.76/device2021-05: 0 reports for this device; peer average 1.76/device2021-06: 0 reports for this device; peer average 1.63/device2021-07: 0 reports for this device; peer average 1.87/device2021-08: 0 reports for this device; peer average 2.03/device2021-09: 0 reports for this device; peer average 1.66/device2021-10: 0 reports for this device; peer average 1.71/device2021-11: 0 reports for this device; peer average 1.97/device2021-12: 0 reports for this device; peer average 1.93/device2022-01: 0 reports for this device; peer average 2.04/device2022-02: 0 reports for this device; peer average 2.04/device2022-03: 0 reports for this device; peer average 1.73/device2022-04: 0 reports for this device; peer average 2.04/device2022-05: 0 reports for this device; peer average 1.88/device2022-06: 0 reports for this device; peer average 2.01/device2022-07: 0 reports for this device; peer average 2.05/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.84/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 2.02/device2022-12: 0 reports for this device; peer average 1.82/device2023-01: 0 reports for this device; peer average 1.72/device2023-02: 0 reports for this device; peer average 1.94/device2023-03: 0 reports for this device; peer average 1.93/device2023-04: 0 reports for this device; peer average 1.92/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2.26/device2023-07: 0 reports for this device; peer average 2.07/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 1.51/device2023-10: 0 reports for this device; peer average 1.56/device2023-11: 0 reports for this device; peer average 1.61/device2023-12: 0 reports for this device; peer average 1.41/device2024-01: 0 reports for this device; peer average 1.99/device2024-02: 0 reports for this device; peer average 1.76/device2024-03: 0 reports for this device; peer average 1.68/device2024-04: 0 reports for this device; peer average 1.77/device2024-05: 0 reports for this device; peer average 1.72/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1.7/device2024-09: 0 reports for this device; peer average 1.71/device2024-10: 0 reports for this device; peer average 1.61/device2024-11: 0 reports for this device; peer average 1.58/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 1.72/device2025-02: 0 reports for this device; peer average 1.56/device2025-03: 0 reports for this device; peer average 1.84/device2025-04: 0 reports for this device; peer average 1.63/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 1.83/device2025-07: 0 reports for this device; peer average 1.71/device2025-08: 0 reports for this device; peer average 1.53/device2025-09: 0 reports for this device; peer average 1.51/device2025-10: 0 reports for this device; peer average 1.62/device2025-11: 0 reports for this device; peer average 1.71/device2025-12: 0 reports for this device; peer average 2.11/device2026-01: 0 reports for this device; peer average 1.87/device2026-02: 0 reports for this device; peer average 1.8/device2026-03: 0 reports for this device; peer average 1.75/device2026-04: 0 reports for this device; peer average 1.7/device2026-05: 0 reports for this device; peer average 1.75/device2026-06: 0 reports for this device; peer average 1.68/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.68
2019-0201.59
2019-0301.68
2019-0401.52
2019-0501.76
2019-0601.87
2019-0701.41
2019-0801.97
2019-0901.48
2019-1001.8
2019-1101.62
2019-1201.74
2020-0101.89
2020-0202.15
2020-0301.76
2020-0401.72
2020-0501.43
2020-0601.8
2020-0701.91
2020-0801.63
2020-0901.92
2020-1002.1
2020-1101.85
2020-1201.82
2021-0101.95
2021-0201.82
2021-0301.98
2021-0401.76
2021-0501.76
2021-0601.63
2021-0701.87
2021-0802.03
2021-0901.66
2021-1001.71
2021-1101.97
2021-1201.93
2022-0102.04
2022-0202.04
2022-0301.73
2022-0402.04
2022-0501.88
2022-0602.01
2022-0702.05
2022-0802
2022-0901.84
2022-1001.87
2022-1102.02
2022-1201.82
2023-0101.72
2023-0201.94
2023-0301.93
2023-0401.92
2023-0502
2023-0602.26
2023-0702.07
2023-0801.67
2023-0901.51
2023-1001.56
2023-1101.61
2023-1201.41
2024-0101.99
2024-0201.76
2024-0301.68
2024-0401.77
2024-0501.72
2024-0601.9
2024-0701.6
2024-0801.7
2024-0901.71
2024-1001.61
2024-1101.58
2024-1201.63
2025-0101.72
2025-0201.56
2025-0301.84
2025-0401.63
2025-0501.75
2025-0601.83
2025-0701.71
2025-0801.53
2025-0901.51
2025-1001.62
2025-1101.71
2025-1202.11
2026-0101.87
2026-0201.8
2026-0301.75
2026-0401.7
2026-0501.75
2026-0601.68
This device (reports/month)Average device in KWS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K103419 — cites (transitively): K042021 (d1), K061454 (d1), K093430 (d1) — cited as predicate by K111379, K162567, K222592

K111379 — cites (transitively): K093430 (d1), K103419 (d1), K042021 (d2), K061454 (d2) — cited as predicate by K212356, K222592

K113309 — cites (transitively): K093430 (d1) — cited as predicate by K162567, K212356

K121220 — cites (transitively): K093430 (d1) — cited as predicate by K162567, K191811, K192365, K212356, K222592

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