EquinoxeRecalls & reported problems across all models

We found 305 models of Equinoxe by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 2,076 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2019 and Sep 30, 2026 — classified as 1 death, 1,913 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (409 reports).

37 FDA recall records name at least one of these models by its device identifier, 34 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Equinoxe recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 3, 2026Open, Classified

   Impactor handle may be missing cross-pin

   Z-1509-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 5, 2025Open, Classified

   Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

   Z-0537-2026 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

3. Sep 5, 2025Open, Classified

   Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

   Z-0536-2026 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

4. Sep 5, 2025Open, Classified

   Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

   Z-0535-2026 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

5. Aug 15, 2025Open, Classified

   Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

   Z-2562-2025 · Root cause: Process design · names 4 of these models · Recall details · FDA record ↗

6. Aug 15, 2025Open, Classified

   Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

   Z-2561-2025 · Root cause: Process design · names 4 of these models · Recall details · FDA record ↗

7. Mar 6, 2024Open, 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).

   Z-1425-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

8. Mar 6, 2024Open, 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).

   Z-1424-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

9. Mar 6, 2024Open, 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).

   Z-1423-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

10. Mar 6, 2024Open, 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).

    Z-1422-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

11. Mar 6, 2024Open, 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).

    Z-1421-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

12. Mar 6, 2024Open, 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).

    Z-1420-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

13. Mar 6, 2024Open, 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).

    Z-1419-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

14. Mar 6, 2024Open, 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).

    Z-1418-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

15. Mar 6, 2024Open, 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).

    Z-1417-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

16. Mar 6, 2024Open, 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).

    Z-1416-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

17. Mar 6, 2024Open, 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).

    Z-1415-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

18. Mar 6, 2024Open, 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).

    Z-1414-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

19. Mar 6, 2024Open, 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).

    Z-1413-2024 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

20. Mar 6, 2024Open, 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).

    Z-1412-2024 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

21. Mar 6, 2024Open, 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).

    Z-1411-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

22. Mar 6, 2024Open, 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).

    Z-1410-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

23. Mar 6, 2024Open, 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).

    Z-1409-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

24. Mar 6, 2024Open, 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).

    Z-1408-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

25. Mar 6, 2024Open, 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).

    Z-1407-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

26. Mar 6, 2024Open, 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).

    Z-1406-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

27. Mar 6, 2024Open, 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).

    Z-1405-2024 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

28. Mar 6, 2024Open, 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).

    Z-1404-2024 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

29. Mar 6, 2024Open, 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).

    Z-1403-2024 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

30. Mar 6, 2024Open, 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).

    Z-1402-2024 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

…and 7 older recalls, listed on each model's page.

Most reported Equinoxe problems

Equinoxe models

305 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Equinoxe 320-38-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 recalls107 reports
• Equinoxe 320-42-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 recalls107 reports
• Equinoxe 320-42-03

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls87 reports
• Equinoxe 320-38-03

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls43 reports
• Equinoxe 320-42-13

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls41 reports
• Equinoxe 320-10-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  132 reports
• Equinoxe 320-36-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls27 reports
• Equinoxe 320-42-10

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls14 reports
• Equinoxe 320-38-13

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls12 reports
• Equinoxe 320-40-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls11 reports
• Equinoxe 320-36-03

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls6 reports
• Equinoxe 320-46-13

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls5 reports
• Equinoxe 320-46-10

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls3 reports
• Equinoxe 314-02-23

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls3 reports
• Equinoxe 321-09-05

  IMPACTOR
  2 recalls3 reports
• Equinoxe 320-36-10

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls1 report
• Equinoxe 320-36-13

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls1 report
• Equinoxe 314-13-03

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall51 reports
• Equinoxe 314-02-24

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls1 report
• Equinoxe 320-40-10

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 recalls1 report
• Equinoxe 314-02-22

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls0 reports
• Equinoxe 314-02-25

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls0 reports
• Equinoxe 314-04-22

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls0 reports
• Equinoxe 314-04-23

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls0 reports
• Equinoxe 314-04-24

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls0 reports
• Equinoxe 314-04-25

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 recalls0 reports
• Equinoxe 300-01-11

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall44 reports
• Equinoxe 320-20-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall42 reports
• Equinoxe 314-13-13

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall42 reports
• Equinoxe 314-13-02

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall39 reports
• Equinoxe 314-13-33

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall38 reports
• Equinoxe 314-13-14

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall32 reports
• Equinoxe 320-46-03

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall23 reports
• Equinoxe 320-46-00

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall22 reports
• Equinoxe 314-13-34

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall18 reports
• Equinoxe 314-13-23

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall13 reports
• Equinoxe 314-13-24

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall13 reports
• Equinoxe 300-30-08

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall11 reports
• Equinoxe 314-02-02

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall10 reports
• Equinoxe 320-01-38

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  60 reports
• Equinoxe 314-13-22

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall10 reports
• Equinoxe 314-13-32

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall10 reports
• Equinoxe 320-38-10

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall9 reports
• Equinoxe 314-02-14

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall8 reports
• Equinoxe 314-13-15

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall8 reports
• Equinoxe 320-40-03

  Shoulder Prosthesis, Reverse Configuration
  1 recall7 reports
• Equinoxe 314-13-04

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall6 reports
• Equinoxe® 322-42-00

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 recall5 reports
• Equinoxe 314-02-03

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall4 reports
• Equinoxe 314-02-13

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall4 reports
• Equinoxe 314-13-35

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall4 reports
• Equinoxe 320-40-13

  Shoulder Prosthesis, Reverse Configuration
  1 recall3 reports
• Equinoxe 314-01-02

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall2 reports
• Equinoxe 314-01-13

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall2 reports
• Equinoxe 314-23-14

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall2 reports
• Equinoxe 314-24-34

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall2 reports
• Equinoxe® 322-38-00

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 recall2 reports
• Equinoxe 314-02-04

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall1 report
• Equinoxe 314-02-15

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-06-23

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-06-25

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-06-34

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 321-00-02

  Shoulder Prosthesis, Reverse Configuration
  1 recall1 report
• Equinoxe 321-00-12

  Shoulder Prosthesis, Reverse Configuration
  1 recall1 report
• Equinoxe 314-23-02

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-23-03

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-23-13

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-24-23

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-24-24

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe 314-24-32

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall1 report
• Equinoxe® 322-38-03

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 recall1 report
• Equinoxe® 322-42-03

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 recall1 report
• Equinoxe 314-01-03

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall0 reports
• Equinoxe 314-01-04

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-01-12

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall0 reports
• Equinoxe 314-01-14

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall0 reports
• Equinoxe 314-02-12

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall0 reports
• Equinoxe 314-13-25

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-06-22

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-06-24

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-06-32

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-06-33

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-06-35

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 321-00-01

  Shoulder Prosthesis, Reverse Configuration
  1 recall0 reports
• Equinoxe 321-00-11

  Shoulder Prosthesis, Reverse Configuration
  1 recall0 reports
• Equinoxe 321-00-21

  Shoulder Prosthesis, Reverse Configuration
  1 recall0 reports
• Equinoxe 321-00-22

  Shoulder Prosthesis, Reverse Configuration
  1 recall0 reports
• Equinoxe 314-23-15

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-24-22

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-24-33

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 314-24-35

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 recall0 reports
• Equinoxe 301-11-11

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 recall0 reports
• Equinoxe 321-59-42

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 recall0 reports
• Equinoxe 321-59-46

  shoulder prosthesis, reverse configuration
  1 recall0 reports
• Equinoxe 320-15-01

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  43 reports
• Equinoxe 320-01-42

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  39 reports
• Equinoxe 320-15-05

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  35 reports
• Equinoxe 320-10-05

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  34 reports
• Equinoxe 300-30-06

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  28 reports
• Equinoxe 315-25-00

  PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  27 reports

Recent Equinoxe adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a left shoulder replacement. Subsequently, the patient experienced swelling and pain at the surgical site and was revised due to a suspected infection. The patient had been treated for recurrent UTIs and was receiving antibiotic therapy. Revision surgery was performed and included irrigation and debridement, collection of tissue samples/biopsies, and replacement of the polyethylene component. The patient was last known to be in stable condition following the event.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50950396 ↗
• InjurySep 30, 2026Detachment of Device or Device Component

  Patient problems: Joint Dislocation

  MAUDE report 50945417 ↗
• InjurySep 30, 2026Detachment of Device or Device Component

  As reported, approximately 7 years and 7 months post the initial right total shoulder arthroplasty, the patient was revised due to the poly disengaging and the shoulder dislocating. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.

  Patient problems: Joint Dislocation

  MAUDE report 50945327 ↗
• InjurySep 29, 2026Naturally Worn

  As reported, the patient underwent an initial total shoulder arthroplasty. Approximately 4 months post the first revision surgery, the patient underwent another revision due to liner disassociation due to the patient "falling". All implants were removed and replaced with competitor products. There was no reported breakage of device or surgical delay/prolongation.

  Patient problems: Fall

  MAUDE report 50936311 ↗
• InjurySep 29, 2026Detachment of Device or Device Component

  Patient problems: Fall

  MAUDE report 50936145 ↗
• InjurySep 24, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50885954 ↗
• InjurySep 23, 2026Detachment of Device or Device Component

  Report #2 of 2.It was reported this patient had a right reverse total shoulder arthroplasty. Subsequently, eight (8) years, nine (9) months later, the patient underwent a revision procedure for an unknown reason. Intraoperatively, the surgeon observed a fractured humeral tray and the humeral liner disassociated from the humeral tray. Additionally, it was reported the patient admitted to no wrongdoing in rehab or exercise to cause this damage. The Patient was last known to be in stable condition following the event. No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50869846 ↗
• InjurySep 21, 2026Naturally Worn

  It was reported that the patient underwent a right shoulder replacement. Subsequently, the patient experienced implant loosening and an infection. As a result, the patient had a revision procedure, with removal of all implants and implantation of a competitive system per surgeon preference. The patient was last known to be in stable condition following the event. No further information has been provided.

  Patient problems: Unspecified Infection

  MAUDE report 50841215 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  As reported, the patient underwent an initial right reverse total shoulder arthroplasty. Subsequently, the patient was revised due to poly failure. The tray, liner, and glenosphere were swapped. The stem and baseplate were well fixed. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.

  Patient problems: Insufficient Information

  MAUDE report 50837791 ↗
• InjurySep 18, 2026Insufficient Device Problem Information

  As reported, approximately 9 years and 3 months post the initial left total shoulder arthroplasty, the patient complained of pain and was revised due to a failed glenoid component. During the revision surgery, the stem came up when trying to get the head off. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.

  Patient problems: Pain

  MAUDE report 50827617 ↗
• InjurySep 18, 2026Fracture

  It was reported that a drill bit fractured during use. Specifically, the tip of the drill bit broke off and remained embedded in the patients glenoid. The fragment was not retrieved, as it was determined that attempting removal could have caused greater harm to the patient. The patient was reported to be functioning well following surgery. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820974 ↗
• InjurySep 18, 2026Migration

  It was reported that the patient underwent a right shoulder replacement. Subsequently, the patient experienced pain associated with humeral stem subsidence. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Pain

  MAUDE report 50820771 ↗
• InjurySep 18, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50820084 ↗
• InjurySep 18, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50819643 ↗
• InjurySep 18, 2026Structural Problem

  Patient problems: Pain

  MAUDE report 50819180 ↗

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