Equinoxe 315-25-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862085313), received between Sep 25, 2019 and Aug 29, 2023 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

10 other recalls cover devices cleared under the same FDA submission (K042021, K093430); 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL USE ON A MALE PATIENT, THE SURGEON WAS REAMING THE GLENOID, THE SPRING INSIDE THE TRI DRIVE HEAD SNAPPED, RESULTING IN IT NO LONGER BEING ABLE TO HOLD ONTO/CONNECT TO THE REAMER. THERE WAS NO EVIDENCE OF INAPPROPRIATE USE. THERE WAS A SPARE SO IT DID NOT IMPACT THE OPERATION. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. NO SURGICAL DELAY/PROLONGATION. UNABLE TO OBTAIN X-RAYS. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641445 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT THE REAM AND THE MECHANISM AT THE BOTTOM WHERE IT CONNECTS BECAME LOOSE AND STOPPED WORKING PROPERLY. IT DID NOT IMPACT THE CASE OUTCOMES AND PIECES DID NOT FALL IN TO THE WOUND SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723183 ↗
• MalfunctionNov 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGICAL USE THE DEVICE BROKE DURING REAMING. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. ALL PIECES WERE ACCOUNTED FOR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756383 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CASE, THE SURGEON WAS DRILLING, AND A PIN FELL OUT OF THE DRILL AND ONTO THE FLOOR. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THE EVENT DID NOT EFFECT THE SURGICAL OUTCOME. PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743898 ↗
• InjuryOct 27, 2022Break; Break

  THE INSTRUMENT COULD HAVE BEEN BROKEN DURING THE SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN¿T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681176 ↗
• MalfunctionJul 27, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ON THE BACK TABLE, DURING THE CASE, THE PIN FELL FROM THE MODULAR CANNULATED TRI-DRIVE DRIVER. WE TOOK THE DRILL FROM THE ANATOMIC SET WITH NO EFFECT ON THE SURGERY. AFTER THE PIN FELL ON THE FLOOR IT WAS LOCATED AND STORED SAFELY. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115690 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT CAME PART DURING REAMING. NO PARTS OR PIECES FELL INTO THE (B)(6) MALE PATIENT WOUND SITE, ALL PIECES ACCOUNTED FOR. PATIENT OUTCOME UNAFFECTED. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521045 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE, THE REAMER CAME APART, SPRING CAME LOOSE. THE TRI-DRIVE CAME LOOSE DURING REAMING SO SURGEON STOPPED USING IT AND USED ANOTHER ONE. NO PARTS OR PIECES FELL INTO THE (B)(6) PATIENT'S WOUND SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14237747 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED FROM THE US THAT DURING AN ORTHOPEDIC SURGERY THE SPRING BROKE WHILE DRILLING PERIPHERAL HOLES. NO DEVICE PARTS OR PIECES FELL INTO THE SURGICAL SITE. THE PATIENT¿S HEALTH WAS STABLE LEAVING THE OR. THE ONLY EFFECT TO THE CASE WAS A DELAY IN TIME OF COMPLETION DUE TO GOING TO GRAB ANOTHER REPLICATOR PLATE. NO PROBLEMS WERE NOTED FOR THE PATIENT RELATED TO PROCEDURE OUTCOME/RESULT. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976098 ↗
• InjuryDec 7, 2021Break; Break

  AS REPORTED, DURING LOADING A DRILL BIT AT THE BACK TABLE, THE SPRING MECHANISM INSIDE DETACHED AS WE WERE TRYING TO LOAD A DRILL ON IT. NO PARTS OR PIECES FELL INTO THE PATIENT. THERE WAS A SMALL DELAY TO WAIT FOR ANOTHER TRAY WHICH HAD ANOTHER DRIVE HANDLE INSIDE. THE (B)(6) MALE PATIENT WAS NOT EFFECTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955015 ↗
• MalfunctionNov 24, 2021Break; Break

  AS REPORTED, DURING SURGICAL USE, THE INSTRUMENT CAME APART DURING REAMING. NO PARTS OR PIECES FELL INTO THE (B)(6) MALE PATIENT¿S WOUND SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868447 ↗
• MalfunctionNov 24, 2021Break; Break

  AS REPORTED, INSTRUMENT BROKE FINAL STAGES OF REAMING GLENOID, NOTICED ON BACK TABLE THE SLEEVE HAD COME LOOSE AND WAS NO LONGER HOLDING THE REAMER EFFECTIVELY. ALL PIECES RETAINED. SWAPPED OUT FOR THE TRI-DRIVE ON THE OTHER SET THEY HAVE NO PATIENT IMPACT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868415 ↗
• MalfunctionOct 5, 2021Break; Break

  AS REPORTED, THE END OF THE MODULAR TRI DRIVE BROKE DURING REAMING. ALL PIECES WERE ACCOUNTED FOR. THE (B)(6) Y/O MALE PATIENT WAS NOT IMPACTED AND WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT THE DEVICE IS TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12575868 ↗
• MalfunctionAug 2, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED, DURING A PROCEDURE, THE TRI DRIVE SPRING BECAME JAMMED WHEN SWITCHING IN BETWEEN REAMER SIZES. IN AN EFFORT TO ¿UNJAM¿ THE TRI DRIVE THE SPRING IS NO LONGER CONNECTED TO THE INSTRUMENT. THE PATIENT WAS CHECKED FOR DEBRIS, CONFIRMED WITH SURGICAL STAFF AND CONTINUED ON WITH THE DELAY TO THE JOINT REPLACEMENT. NO ONE WAS HARMED AND THE PATIENT IS LAST KNOWN TO BE IN STABLE CONDITION. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258535 ↗
• MalfunctionJun 11, 2021Break; Break

  WHILE REAMING THE GLENOID, THE SPRING AND COLLAR FROM THE HANDLE BROKE OFF. HANDLE WAS REPLACED, ALL PARTS WERE RETRIEVED. NO ADVERSE EFFECTS TO THE PATIENT OR THE OUTCOME OF THE CASE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11985000 ↗
• MalfunctionMay 7, 2021Break; Break

  AS REPORTED, THE INSTRUMENT BROKE DURING USE, THE SCRUB NOTICED THAT THE PIECES INVOLVED IN THE MECHANISM FOR INSERTING THE REAMERS/DRILL BITS HAD COME LOOSE. SWAPPED OUT FOR THE TRI-DRIVE ON THE OTHER SET THEY HAVE ¿ NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789531 ↗
• MalfunctionApr 9, 2021Break; Break

  AS REPORTED, THE COLLAR ON TRI DRIVE BROKE WHEN REAMING GLENOID. THE BREAK WAS CAUGHT BEFORE THE INSTRUMENT BROKE COMPLETELY. NO PIECES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640353 ↗
• MalfunctionMar 10, 2021Break; Break

  AS REPORTED, PRIOR TO USE IT WAS NOTED THAT THE COLLAR/SPRING CAME LOOSE. UNSURE WHEN THIS HAPPENED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11451618 ↗
• MalfunctionMar 3, 2021Break; Break

  AS REPORTED, WHILE REAMING, THE SPRING IN THE TRI-DRIVE HANDLE SEEMED TO COME LOOSE. THE HANDLE WAS REPLACED, NO ISSUES WITH SURGERY, NO DELAY. THE MALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404559 ↗
• InjuryFeb 8, 2021Break; Break

  AS REPORTED, DURING AN INITIAL PROCEDURE ON A MALE PATIENT, THE SURGEON WAS USING THE TRI-DRIVER TO REAM THE GLENOID AND ¿THE COLLAR FROM THE TRI DRIVE MODULAR HANDLE SPRUNG OFF¿ AND THE REAMER FELL WITH IT. THE SPRING WAS BROKEN, AND WE WERE UNABLE TO FIX THE COLLAR. THE COLLAR AND REAMER FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO REMOVE BOTH PARTS THAT FELL INTO THE OPEN WOUND. DELAY WAS DUE TO THE REAMER BREAKING, HAVING TO GET OUT THE TWO PRODUCTS THAT LANDED IN THE OPEN WOUND, OPEN A NEW TRAY AND PUT THE NEW DRIVER ONTO POWER TO CONTINUE WITH THE PROCEDURE. PATIENT HAD NO IMPLANTS PRIOR TO THE PROCEDURE THAT I KNOW ABOUT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11292345 ↗
• MalfunctionDec 2, 2020Break; Break

  AS WAS REPORTED, THIS INSTRUMENT WAS FOUND TO BE BROKEN DURING SET UP. IT WAS NOT USED ON A PATIENT. THERE WAS NO SURGICAL DELAY. 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 10936897 ↗
• MalfunctionDec 2, 2020Break; Break

  AS REPORTED, DURING USE ON A (B)(6) Y/O MALE PATIENT, THE TRI DRIVE DISTAL COLLAR BROKE WHILE REAMING THE GLENOID. THE SPRING CAME OUT AND COLLAR FELL OFF. THE TRI DRIVE WAS STILL USED AFTERWARDS TO STILL DRILL THE CENTER GLENOID HOLE BEFORE ANOTHER TRAY COULD BE OPENED WITH A SECOND TRI-DRIVE. NO PARTS OR PIECES FELL INTO THE WOUND. NO COMPLICATIONS, OR ISSUES TO 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 10935302 ↗
• MalfunctionOct 13, 2020Break; Break

  AS REPORTED, AFTER PASSING THE STARTER REAMER, THE SURGEON POSITIONED HIMSELF TO USE THE REAMER SIZE 38MM. AT THE BEGINNING OF STARTING TO REAM, THE LOCKING SYSTEM OF THE DEVICE HAD UNLOCKED WITHOUT RUBBING ON THE RETRACTORS OR AN ESPECIALLY DENSE BONE. WE USED THE SECOND DEVICE, #3152500, THAT WAS AVAILABLE. THE BROKEN DEVICE WILL BE RETURNED. THERE WAS NO INCIDENT TO THE PATIENT AND THE RESULTS OF THE SURGERY WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670354 ↗
• MalfunctionJul 15, 2020Break; Break

  AS REPORTED, DURING A CASE, AFTER DRILLING THE TIP OF THE TRI DRIVE FELL APART ON THE BACK TABLE. IT APPEARS AS THOUGH THE SPRING-LOADED COMPONENT HAS FAILED. NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE, THE DRIVER BROKE ON THE BACK TABLE AFTER DRILLING. 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 10275685 ↗
• 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 9769023 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty