Equinoxe 321-20-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862087584), received between Sep 29, 2022 and Jul 9, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2024Break; Fracture; Break; Fracture

  AS REPORTED, THE 2.0 MM DRILL BROKE WHILE THE SURGEON WAS DRILLING THE PILOT HOLE. THIS EVENT IS RELATED TO THE BREAKAGE OF THE DEVICE. ALL PIECES THAT FELL INTO THE PATIENT AND/OR THE WOUND SITE WERE REMOVED. THE EVENT DID NOT CAUSE A SURGICAL DELAY/PROLONGATION. THE EVENT IS NOT RELATED TO A REVISION OF EXACTECH DEVICES. NO DEVICE RETURN FOR ANALYSIS ANTICIPATED. THE SCRUB PLACED THE SINGLE USE ITEM IN THE SHARPS BIN. A DEVICE IMAGE WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707399 ↗
• InjuryJun 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS DRILLING WITH THE 2MM DRILL THROUGH THE PILOT HOLE OF THE MODULAR GLENOID PLATE DRILL GUIDE WHEN THE DRILL BROKE. SURGERY CONTINUED AS NORMAL. NO FRAGMENT PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. NO PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484069 ↗
• MalfunctionOct 24, 2022Break; Fracture; Break; Fracture

  AS REPORTED, THE DRILL BIT UTILIZED FOR PROCEDURE BROKE IN TWO (2) PIECES DURING USE. BOTH PORTIONS RETRIEVED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658184 ↗
• MalfunctionSep 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANT PROCEDURE, WHEN ATTEMPTING TO DRILL A HOLE FOR THE REVERSE BASEPLATE, THE DRILL BIT UNFORTUNATELY SNAPPED OFF WITHIN THE DRILL GUIDE. NO PARTS OR PIECES FELL INTO THE WOUND SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504813 ↗

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-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-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-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-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-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-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-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.