Equinoxe 321-25-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885862087621), received between Oct 3, 2019 and Mar 21, 2023 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, A REAMER AND TRI-DRIVER BROKE. NO PARTS OR PIECES FELL INTO THE PATIENT. THERE WAS NO SURGICAL DELAY. THE DEVICES WERE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588343 ↗
• InjuryMay 25, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE, THE SURGEON WAS REAMING THE GLENOID AND SUDDENLY THE REAMER BEGAN TO SLIP. UPON INVESTIGATION THE TIP WAS BROKEN. THE SURGEON REMOVED THE TIP AND CONTINUED TO REAM WITH THE 42MM REAMER. PART OF THE DEVICE WAS REMOVED FROM THE (B)(6) MALE PATIENT. THERE WAS NO DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498469 ↗
• InjuryNov 11, 2021Break; Break

  AS REPORTED, WHILE SURGEON WAS REAMING DURING A PROCEDURE ON THIS (B)(6) Y/O FEMALE, THE PILOT TIP BROKE OFF IN THE PATIENT¿S BONE. X-RAY WAS TAKEN TO CONFIRM WHERE THE TIP WAS. THE SURGEON COULD NOT RETRIEVE IT AND IT WAS LEFT IN THE PATIENT'S BONE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12795808 ↗
• InjurySep 22, 2021Break; Break

  AS REPORTED, THE TIP OF REAMER BROKE OFF WHILE REAMER GLENOID. BROKEN PIECE WAS EASILY RETRIEVED. NO TIME WAS ADDED TO THE SURGERY AND PATIENT LEFT THE OR IN GOOD HEALTH. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511744 ↗
• InjuryMay 7, 2021Break; Break

  AS REPORTED, THE SURGEON WAS NAVIGATING A TOTAL SHOULDER AND WAS REAMING THE GLENOID OF THIS (B)(6) Y/O MALE PATIENT. THE REAMER TIP BROKE DURING THE PROCESS. IT BROKE DURING REAMING, BUT NO DAMAGE WAS DONE TO THE PATIENT. THE REAMER WAS EXCHANGED. THE PILOT TIP WAS REMOVED VERY EASILY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789545 ↗
• InjuryFeb 24, 2021Break; Break

  AS REPORTED THE PILOT TIP ON THE END OF THE REAMER BROKE OF DURING THE REAMING PORTION OF THE PROCEDURE. THE TIP WAS FOUND AND WE CONTINUED TO REAM WITH THE NEXT SIZE UP. THIS CAUSED NO DELAY, NO HARM TO THE PATIENT, AND WE CONTINUED THE PROCESS WITH NO ISSUES. THE PATIENT HAD NO ISSUES RELATED TO THE PROCEDURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11371606 ↗
• InjuryJan 8, 2021Break; Break

  AS REPORTED, THE SURGEON WAS REAMING THE GLENOID USING THE PILOT-TIPPED 38MM GLENOID REAMER AND THE TIP BROKE OFF INSIDE OF PATIENT. THE PILOT TIP OF GLENOID REAMER PILOT TIP WAS RETRIEVED AFTER CREATING SPACE WITHIN THE HOLE. AFTER RETRIEVAL OF GLENOID TIP, REVERSE SHOULDER CONTINUED WITHOUT ISSUE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS A REPORTED DELAY OF 5-15 MINUTES WITH NO CONSEQUENCES TO THE PATIENT NOTED. THE DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11143347 ↗
• InjuryOct 8, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE ON THIS (B)(6) Y/O FEMALE PATIENT, THE PILOT TIP OF THE REAMER BROKE OFF INSIDE THE PATIENT. THE DOCTOR WAS UNABLE TO GET IT OUT, SO THE TIP WAS LEFT INSIDE THE PATIENT. X-RAY WAS BROUGHT INTO THE ROOM TO CONFIRM THAT THE TIP IS STILL IN THE PATIENT. THERE WAS A SHORT DELAY OF 5-15 MINUTES WITH NO ADDITIONAL ADVERSE EVENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO RETURN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10648040 ↗
• InjurySep 21, 2020Break; Break

  AS REPORTED, WHILE REAMING ON THIS (B)(6) Y/O MALE, THE PILOT TIP REAMER BROKE OFF. TIP WAS RECOVERED BUT DISPOSED OF. 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 10559669 ↗
• 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 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 10460069 ↗
• MalfunctionJul 28, 2020Break; Break

  TIP OF REAMER BROKE OFF WHILE REAMING. THE TIP WAS RECOVERED. THE (B)(6) Y/O FEMALE 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 10332997 ↗
• InjuryApr 3, 2020Break; Break

  AS REPORTED, PILOT TIP BROKE OFF OF PILOT TIP REAMER DURING REAMING OF GLENOID. PILOT TIP WAS NOT REMOVED FROM GLENOID, SURGEON DEEMED IT A GREATER RISK TO DIG THROUGH GLENOID THAN JUST DRILL OVER WITH CENTER CAGE AND LEAVE IN. DEVICE IS NOT RETURNING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9923746 ↗
• InjuryMar 9, 2020Break; Break

  AS REPORTED, DURING REAMING THE TIP OF THE REAMER BROKE OFF. THE BROKEN TIP WAS RETRIEVED. THE EVENT DID NOT LEAD TO PATIENT INJURY. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9804967 ↗
• MalfunctionFeb 28, 2020Break; Break

  WHILE REAMING THE GLENOID WITH THE 38MM PILOT TIP REAMER THE PILOT TIP BROKE OFF OF THE REAMER. IT WAS RECOVERED FROM THE GLENOID AND DISPOSED OF APPROPRIATELY. THE PATIENT WAS NOT HARMED. ALSO WHILE REAMING THE GLENOID A SHORT TIME LATER THE END OF THE TRI DRIVE SHAFT BROKE AND CAME APART. THE SPRINGS CAME LOOSE AND THE END CAP COMPLETELY CAME APART FROM THE DRIVER SHAFT. ALL PIECES WERE RECOVERED FROM THE PATIENT AND NO HARM WAS DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9769025 ↗
• MalfunctionDec 3, 2019Break; Break

  AS REPORTED, DURING THE REAMER PART OF A REVERSE SHOULDER PROCEDURE, THE PATIENT WAS LARGE AND EXPOSURE WAS TOUGH. THE SURGEON TRIED TO REAM A POSTERIOR/SUPERIOR RIGHT AUGMENT WITH THE PILOT TIP REAMER, INSTEAD OF THE CANNULATED OPTION AFTER REMOVING THE K-WIRE DUE TO SOME DIFFICULTY WORKING WITH THE GLENOID. IT WAS ALSO VERY HARD BONE. THE PILOT TIP OF THE REAMER THEN BROKE OFF INSIDE OF THE PATIENT AND HE HAD TO USE A MANUAL TOOL TO REMOVE THE TIP FROM THE PATIENT. THERE WAS NO PATIENT IMPACT AND THE SITUATION WAS RESOLVED RATHER QUICKLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403609 ↗
• MalfunctionOct 31, 2019Break

  IT WAS REPORTED THAT THE SURGEON WAS BEGINNING TO PREPARE THE GLENOID FOR THE BASEPLATE. HE BEGAN REAMING AS USUAL AND IMMEDIATELY AFTER STARTING TO REAM THE PILOT TIP OF THE REAMER BROKE OFF AND WAS LEFT BEHIND IN THE GLENOID. HE STOPPED REAMING AND TOOK TIME TO RETRIEVE THE SMALL PILOT TIP THAT WAS STILL INSIDE THE BONE. IT TOOK HIM 5-10 MINUTES, BUT HE EVENTUALLY REMOVED IT. AND HE CONTINUED PREPARING THE GLENOID AND THE CASE WAS FINISHED IN THE NORMAL FASHION.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9264691 ↗
• MalfunctionOct 31, 2019Break

  IT WAS REPORTED THAT WHILE GLENOID REAMING WITH THE 38MM-PILOT TIP REAMER, THE PILOT TIP HAS BROKEN OFF THE REAMER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9264671 ↗
• MalfunctionOct 18, 2019Break; Detachment of Device or Device Component; Break

  IT WAS REPORTED THAT THE PILOT TIP CAME OFF.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9207514 ↗
• MalfunctionOct 3, 2019Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PILOT TIP ON THE 38MM PILOT TIP REAMER SNAPPED OFF AND BECAME EMBEDDED IN THE GLENOID. THE SURGEON MAY HAVE BEEN A LITTLE OVERZEALOUS WITH THE REAMER, WHICH CAUSED IT TO BREAK. REPRESENTATIVE ADVISED THAT THE SURGEON SHOULD REMOVE THE PILOT TIP BUT THE SURGEON STATED THAT HE WAS UNABLE TO, THEN ON SUBSEQUENT ATTEMPTS TO TRY AND REMOVE IT HE STATED THAT HE HAD ACTUALLY PUSHED IT FURTHER INTO THE GLENOID AND THERE WAS NO WAY HE WAS GETTING IT OUT. THE PILOT TIP REMAINS INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9152333 ↗

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-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-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-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-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-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-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-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-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-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-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-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-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0414-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t

…and 3 more.