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Equinoxe

Model SPI-038814 · Exactech, Inc. · DI 10885862596079

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 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (17)

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.k number procode
2024-03-06Z-1416-2024Class 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).k number procode
2024-03-06Z-1417-2024Class 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).k number procode
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).k number procode
2024-03-06Z-1419-2024Class 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).k number procode
2024-03-06Z-1422-2024Class 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).k number procode
2024-03-06Z-1423-2024Class 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).k number procode
2024-03-06Z-1424-2024Class 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).k number procode
2024-03-06Z-1425-2024Class 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).k number procode
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.k number procode
2020-09-25Z-0308-2021Class IITerminatedThe device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.k number procode
2020-09-25Z-0307-2021Class IITerminatedThe device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.k number procode
2020-08-24Z-3019-2020Class IITerminatedExactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.k number procode
2020-08-24Z-3020-2020Class IITerminatedExactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.k number procode
2019-12-03Z-0872-2020Class IITerminatedLabels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.k number procode
2019-12-03Z-0873-2020Class IITerminatedLabels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.k number procode
2012-06-15Z-2118-2012Class IITerminatedExactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five yeark 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.

11232019-01: 0 reports for this device; peer average 1.83/device2019-02: 0 reports for this device; peer average 1.78/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 1.95/device2019-05: 0 reports for this device; peer average 2.13/device2019-06: 0 reports for this device; peer average 1.89/device2019-07: 0 reports for this device; peer average 1.69/device2019-08: 0 reports for this device; peer average 2.18/device2019-09: 0 reports for this device; peer average 1.67/device2019-10: 0 reports for this device; peer average 1.91/device2019-11: 0 reports for this device; peer average 1.68/device2019-12: 0 reports for this device; peer average 1.81/device2020-01: 0 reports for this device; peer average 1.94/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.16/device2020-04: 0 reports for this device; peer average 1.75/device2020-05: 0 reports for this device; peer average 1.71/device2020-06: 0 reports for this device; peer average 2.03/device2020-07: 0 reports for this device; peer average 2.21/device2020-08: 0 reports for this device; peer average 1.84/device2020-09: 0 reports for this device; peer average 2.01/device2020-10: 0 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 1.95/device2020-12: 0 reports for this device; peer average 1.88/device2021-01: 0 reports for this device; peer average 2.19/device2021-02: 0 reports for this device; peer average 1.91/device2021-03: 0 reports for this device; peer average 2.09/device2021-04: 0 reports for this device; peer average 2.01/device2021-05: 0 reports for this device; peer average 1.92/device2021-06: 0 reports for this device; peer average 1.84/device2021-07: 0 reports for this device; peer average 2.11/device2021-08: 0 reports for this device; peer average 2.23/device2021-09: 0 reports for this device; peer average 1.96/device2021-10: 0 reports for this device; peer average 2.18/device2021-11: 0 reports for this device; peer average 2.07/device2021-12: 0 reports for this device; peer average 2.55/device2022-01: 0 reports for this device; peer average 2.6/device2022-02: 0 reports for this device; peer average 2.39/device2022-03: 0 reports for this device; peer average 2.46/device2022-04: 0 reports for this device; peer average 2.43/device2022-05: 0 reports for this device; peer average 2.06/device2022-06: 0 reports for this device; peer average 2.31/device2022-07: 0 reports for this device; peer average 2.22/device2022-08: 0 reports for this device; peer average 2.24/device2022-09: 0 reports for this device; peer average 2.03/device2022-10: 0 reports for this device; peer average 2.03/device2022-11: 0 reports for this device; peer average 2.13/device2022-12: 0 reports for this device; peer average 2.09/device2023-01: 0 reports for this device; peer average 1.83/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1.98/device2023-04: 0 reports for this device; peer average 2.14/device2023-05: 0 reports for this device; peer average 2.06/device2023-06: 0 reports for this device; peer average 2.23/device2023-07: 0 reports for this device; peer average 2.09/device2023-08: 0 reports for this device; peer average 1.75/device2023-09: 0 reports for this device; peer average 1.57/device2023-10: 0 reports for this device; peer average 1.61/device2023-11: 0 reports for this device; peer average 1.69/device2023-12: 0 reports for this device; peer average 1.44/device2024-01: 0 reports for this device; peer average 1.85/device2024-02: 0 reports for this device; peer average 1.91/device2024-03: 0 reports for this device; peer average 1.71/device2024-04: 0 reports for this device; peer average 1.87/device2024-05: 0 reports for this device; peer average 1.72/device2024-06: 0 reports for this device; peer average 1.89/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.71/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 1.74/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 1.75/device2025-02: 0 reports for this device; peer average 1.68/device2025-03: 0 reports for this device; peer average 1.9/device2025-04: 0 reports for this device; peer average 1.82/device2025-05: 0 reports for this device; peer average 1.9/device2025-06: 0 reports for this device; peer average 1.93/device2025-07: 0 reports for this device; peer average 1.74/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.49/device2025-10: 0 reports for this device; peer average 1.66/device2025-11: 0 reports for this device; peer average 1.74/device2025-12: 0 reports for this device; peer average 2.16/device2026-01: 0 reports for this device; peer average 1.9/device2026-02: 0 reports for this device; peer average 1.79/device2026-03: 0 reports for this device; peer average 1.79/device2026-04: 0 reports for this device; peer average 1.73/device2026-05: 0 reports for this device; peer average 1.76/device2026-06: 0 reports for this device; peer average 1.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.83
2019-0201.78
2019-0301.68
2019-0401.95
2019-0502.13
2019-0601.89
2019-0701.69
2019-0802.18
2019-0901.67
2019-1001.91
2019-1101.68
2019-1201.81
2020-0101.94
2020-0202.07
2020-0302.16
2020-0401.75
2020-0501.71
2020-0602.03
2020-0702.21
2020-0801.84
2020-0902.01
2020-1002.25
2020-1101.95
2020-1201.88
2021-0102.19
2021-0201.91
2021-0302.09
2021-0402.01
2021-0501.92
2021-0601.84
2021-0702.11
2021-0802.23
2021-0901.96
2021-1002.18
2021-1102.07
2021-1202.55
2022-0102.6
2022-0202.39
2022-0302.46
2022-0402.43
2022-0502.06
2022-0602.31
2022-0702.22
2022-0802.24
2022-0902.03
2022-1002.03
2022-1102.13
2022-1202.09
2023-0101.83
2023-0202
2023-0301.98
2023-0402.14
2023-0502.06
2023-0602.23
2023-0702.09
2023-0801.75
2023-0901.57
2023-1001.61
2023-1101.69
2023-1201.44
2024-0101.85
2024-0201.91
2024-0301.71
2024-0401.87
2024-0501.72
2024-0601.89
2024-0701.63
2024-0801.71
2024-0901.75
2024-1001.74
2024-1101.67
2024-1201.71
2025-0101.75
2025-0201.68
2025-0301.9
2025-0401.82
2025-0501.9
2025-0601.93
2025-0701.74
2025-0801.67
2025-0901.49
2025-1001.66
2025-1101.74
2025-1202.16
2026-0101.9
2026-0201.79
2026-0301.79
2026-0401.73
2026-0501.76
2026-0601.75
This device (reports/month)Average device in KWS, KWT, PHX (reports/device/month)

Regulatory clearances

  • K150458 SESE 2015-05-14 (k number procode)
  • K131575 SESE 2013-07-03 (k number procode)
  • K110708 SESE 2011-04-01 (k number procode)
  • K101909 SESE 2010-08-02 (k number procode)
  • K093275 SESE 2010-05-27 (k number procode)

Predicate lineage

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

K073688 — cited as predicate by K150568

K082702 — cited as predicate by K191561, K213546, K223833

K093275 — cited as predicate by K162567, K180632, K193098, K213546, K223833, K260583

K102951 — cited as predicate by K180632

K110708 — cited as predicate by K161742, K162325, K162567, K172502, K180632, K193098, K211359

K131575 — cited as predicate by K162567, K180632

K150458 — cites (transitively): K063569 (d1) — cited as predicate by K193098, K252352

K193098 — cites (transitively): K063569 (d1), K093275 (d1), K110708 (d1), K150458 (d1)

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