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Equinoxe 321-55-42Recalls & reported problems

Exactech, Inc. · REAMER, MODULAR, REVERSE, CANNULATED, NARROW, 42mm · Class 2

All models of Equinoxe (305)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862232779), received between Nov 18, 2020 and Sep 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K063569); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2021No Apparent Adverse Event; No Apparent Adverse Event

    AS REPORTED, WHILE REAMING THE GLENOID OF A PATIENT, THE BUTTERFLY REAMERS WERE SPINNING ON THE FACE. THE SURGEON WAS ADAMANT THAT THE REAMERS ARE TOO BLUNT FOR HARD BONE AND THAT THEY SHOULD BE REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12445477 ↗
  • MalfunctionNov 18, 2020Break; Break

    AS REPORTED, DURING A PROCEDURE ON A MALE PATIENT, AS THE REAMER WAS BEING TAKEN OFF MODULAR DRIVER AFTER REAMING WAS FINISHED THE TIP BROKE INTO 2 PIECES. NO PARTS OR PIECES FELL INTO THE WOUND SITE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10859768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

  • Z-2561-2025 · Aug 15, 2025 · Open, Classified
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
  • Z-1419-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
  • Z-1423-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
  • Z-1425-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
  • Z-1422-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
  • Z-1424-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
  • Z-1418-2024 · Mar 6, 2024 · Open, Classified
    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
  • Z-0579-2024 · Nov 21, 2023 · Open, Classified
    Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
  • Z-3019-2020 · Aug 24, 2020 · Terminated
    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
  • Z-3020-2020 · Aug 24, 2020 · Terminated
    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
  • Z-0012-2019 · Aug 21, 2018 · Open, Classified
    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
  • Z-0900-2017 · Oct 25, 2016 · Terminated
    Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
  • Z-2117-2012 · Jun 15, 2012 · Terminated
    Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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