Equinoxe 321-25-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862087638), received between Jan 29, 2020 and Jun 26, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

18 other recalls cover devices cleared under the same FDA submission (K042021, K093430, K113309); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2024Break; Break

  AS REPORTED, SURGEON LOST CONTROL OF THE POWER TOOL DURING REAMING PROCESS CAUSING THE REAMER TIP TO BEND WITHIN THE GLENOID AND SNAP OFF. THE EVENT IS NOT ASSOCIATED WITH THE REVISION OF EXACTECH IMPLANTS. THE EVENT IS RELATED TO THE BREAKAGE OF THE DEVICE. FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT AND WERE NOT REMOVED. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN REAMER TIP. SURGEON TOOK AN X-RAY TO ENSURE THE METAL TIP WAS WITHIN BONE AND NOT SOFT TISSUE. THE EVENT LED TO A 15-30 MIN SURGICAL DELAY TO ATTEMPT TO REMOVE THE PART AND TAKE AN X-RAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT/MEDICAL INFORMATION PROVIDED. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 19620958 ↗
• InjuryFeb 5, 2023Break; Break

  AS REPORTED, THE SURGEON WAS PREPARING THE PATIENT'S GLENOID TO RECEIVE A GLENOID BASE PLATE DURING A REVERSE TOTAL SHOULDER PROCEDURE. A 42MM PILOT TIP REAMER WAS BEING USED WHEN THE PILOT TIP FRACTURED AT ITS BASE AND SEPARATED FROM THE REAMER. THE FRACTURED TIP WAS RETRIEVED FROM THE SURGICAL SITE WITHOUT INCIDENT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302096 ↗
• InjuryOct 6, 2022Break; Break

  AS REPORTED, DURING AN INITIAL TSA SURGERY, WHEN USING THE 42 REAMER, THE PILOT TIP SNAPPED OFF WITHIN THE GLENOID AND HAD TO BE RETRIEVED FROM THE BONE USING A BONE NIBBLER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549745 ↗
• InjurySep 8, 2020Break; Break

  AS REPORTED, THE TIP OF REAMER BROKE AS THE SURGEON WAS PULLING OUT OF GLENOID. THE (B)(6) Y/O MALE PATIENT WAS X-RAYED PATIENT NO TIP VISIBLE. SUSPECT THAT TIP WAS IN SUCTION RECEPTACLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10502009 ↗
• InjuryAug 27, 2020Break; Break

  AS REPORTED, THE REAMER TIP BROKE OFF IN PILOT HOLE WHILE REAMING GLENOID OF A MALE PATIENT. THE TIP WAS EASILY RETRIEVED, AND WE USED A DIFFERENT REAMER AFTER THAT. NO HARM WAS DONE TO THE PATIENT. THE CASE ENDED GREAT. AN X RAY WAS TAKEN TO ENSURE NO PARTS WERE LEFT IN THE PATIENT. 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 10460095 ↗
• InjuryAug 14, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE, THE SIZE 42 PILOT TIP REAMER TIP BROKE OFF WHILST REAMING DUE TO HARD SCLEROTIC BONE. SURGEON RETRIEVED THE TIP, NO PATIENT IMPACT. WENT TO A CANNULATED REAMER TO FINISH THE CASE. DEVICE TO BE RETURNED. PATIENT WAS KNOWN TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407521 ↗
• InjuryFeb 4, 2020Break; Break

  AS REPORTED, THE TIP OF A REAMER BROKE OFF WHILE REAMING THE GLENOID. THE TIP OF THE REAMER WAS EASILY RETRIEVED, AND AN X-RAY WAS TAKEN AT THE END OF THE CASE AND NO PIECES WERE LEFT IN THE PATIENT. NO TIME WAS ADDED TO THE CASE AND THE PATIENT LEFT THE OR IN GOOD HEALTH. THE OUTCOME OF THE CASE WAS GOOD. DEVICE WAS RETRIEVED THE BROKEN TIP AND USED ANOTHER REAMER IN THE SET TO COMPLETE THE REAMING. BROKEN PART WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664218 ↗
• MalfunctionJan 29, 2020Break; Break

  AS REPORTED, THE SURGEON PUT TOO MUCH ANGLE AND TORQUE ON THEM AND SNAPPED THE POINT OFF BOTH INSTRUMENTS. THE PATIENT WAS AN OLDER MALE OF AVERAGE BUILD. ALL AVAILABLE INFORMATION RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641864 ↗
• MalfunctionJan 29, 2020Break; Break

  AS REPORTED, THE SURGEON PUT TOO MUCH ANGLE AND TORQUE ON THEM AND SNAPPED THE POINT OFF BOTH INSTRUMENTS. THE PATIENT WAS AN OLDER MALE OF AVERAGE BUILD. NO PIECES FELL INTO THE WOUND. ALL AVAILABLE INFORMATION RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641855 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K093430, K113309. One submission often covers many models, so check the product and lot details in each record.

• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
• Z-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0415-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of

…and 3 more.