Equinoxe 320-20-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10885862086518), received between Apr 3, 2019 and Sep 18, 2026 — classified as 39 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 reports).

1 FDA recall record name this device's identifier.

12 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 25, 2016Terminated

   Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

   Z-0900-2017 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Structural Problem

  Patient problems: Pain

  MAUDE report 50819180 ↗
• InjuryMay 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE HUMERAL TRAY WAS DISSOCIATED FROM THE PRESERVE STEM. THE TORQUE SCREW WAS EXPLANTED AND INTACT (DID NOT APPEAR BROKEN). THE REPORTED EVENT WAS RELATED TO A DEVICE BREAKAGE BUT NO PARTS OR PIECES WERE IN THE WOUND SITE. THE TORQUES SCREW WAS REVISED. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25089265 ↗
• InjuryApr 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT¿S TRAY DISASSOCIATED FROM THE STEM. DEVICE BREAKAGE OCCURRED DURING THE PROCEDURE. THE TRIAL TRAY BROKE DURING THE PROCEDURE ALMOST DAMAGING THE PREVIOUSLY IMPLANTED PRESERVE STEM. NO PARTS OR PIECES FELL INTO THE WOUND SITE AND ALL PARTS AND PIECES WERE REMOVED. THERE WAS NO SURGICAL DELAYS DURING THE PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 24822264 ↗
• InjuryMar 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED VIA A CLINICAL STUDY, THAT A 69 YO MALE PATIENT, WHO HAD A RTSA, UNDERWENT A REVISION PROCEDURE DUE TO DISASSOCIATION OF HUMERAL PLATE. THE REPLICATOR TRAY SCREW STRIPPED AND BACKED OUT OF THE CYLINDRICAL BORE HUMERAL TRAY. THE TRAY AND LINER WERE REPLACED. THE STUDY INDICATES IT WAS DEFINITELY RELATED TO THE DEVICES AND THE PROCEDURE. THE OUTCOME STATES RESOLVED. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24624246 ↗
• InjuryJan 6, 2026Detachment of Device or Device Component; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT REVERSE TOTAL SHOULDER REVISION. SUBSEQUENTLY, THE PATIENT'S TORQUE DEFINING SCREW SEPARATED FROM THE HUMERAL STEM RESULTING IN DISASSOCIATION OF THE HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT AN ADDITIONAL SHOULDER REVISION SURGERY APPROXIMATELY 6 MONTHS AFTER THEIR FIRST REVISION SURGERY AND 6 YEARS AFTER THEIR INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 23981275 ↗
• InjuryDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER REVISION ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT'S HUMERAL STEM AND TORQUE DEFINING SCREW DISASSEMBLED WHICH RESULTED IN DISASSEMBLY OF THE HUMERAL TRAY AND HUMERAL STEM. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 2 YEAR AND 6 MONTHS AFTER INITIAL IMPLANTATION OF THE STEM AND 6 MONTHS AFTER THE FIRST REVISION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23819270 ↗
• InjuryNov 5, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT'S HUMERAL TRAY DISASSOCIATED FROM THE HUMERAL STEM. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER INITIAL IMPLANTATION. DURING THE REVISION IT WAS NOTED THAT THE TORQUE DEFINING SCREW WAS BENT AND HAD SEPARATED FROM THE HUMERAL STEM. THE THREADS IN THE PREVIOUS STEM WERE REPORTED TO BE UNDAMAGED, AND THE STEM WAS RETAINED FOR THE REVISION. CULTURES TAKEN AT THE TIME OF REVISION GREW P. ACNES. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 23477780 ↗
• InjuryOct 21, 2025Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED APPROXIMATELY SIX YEARS AFTER A REVERSE RIGHT TOTAL SHOULDER REPLACEMENT THE PATIENT EXPERIENCED PAIN. THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER REVISION PROCEDURE DUE TO DISASSOCIATION OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND LOCKING SCREW. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 23351041 ↗
• InjuryAug 20, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED APPROXIMATELY FIVE (5) YEARS AFTER A LEFT REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, A PATIENT UNDERWENT A REVISION PROCEDURE OF THE HUMERAL TRAY, LINER AND HUMERAL STEM. X-RAYS AND IMAGES WERE PROVIDED. OBSERVATIONS OF THE TRAY AND LINER NOTED THE TORQUE SCREW WAS INTACT BETWEEN THE LINER AND THE TRAY BUT THERE WAS NO SCREW THREADS LEFT. THERE WAS NO SCREW OBSERVED ON X RAY, AND NO METALLOSIS OBSERVED. IT WAS REPORTED THE SURGEON COULD NOT FIND THE THREADED PART OF THE BREAK OFF SCREW ANYWHERE IN THE STEM OR THE PATIENT. THE HUMERAL LINER WAS NOTED TO HAVE MINIMAL WEAR. THERE WERE NO SURGICAL DELAYS OR PROLONGATION. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22854790 ↗
• InjuryAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE. X RAYS SHOWED THAT THE HUMERAL TRY AND TORQUE DEFINING SCREW DISASSOCIATED FROM THE HUMERAL STEM. INTRA-OPERATIVE FINDINGS CONFIRMED THIS TO BE THE CASE, AS WELL AS DEMONSTRATING THAT HUMERAL LINER WAS DISSOCIATED FROM HUMERAL TRAY. THE THREADED PORTION OF THE TORQUE DEFINING SCREW, WHICH WAS REMOVED, WAS NOT BROKEN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22835672 ↗
• MalfunctionAug 15, 2025Separation Failure; Damaged Thread; Separation Failure; Damaged Thread

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT RTSA (REVERSE TOTAL SHOULDER ARTHROPLASTY). SUBSEQUENTLY, THEIR SHOULDER DISLOCATED, AND THE SURGEON HAD PLANNED TO REMOVE THE +0 HUMERAL LINER/+0 TRAY TO BUILD UP IN SIZE. DURING SURGERY, THE SURGEON HAD NOTICED THAT THE TORQUE SCREW IN THE HUMERAL TRAY WAS STRIPPED, AND HE COULD NOT REMOVE IT. THE SURGEON WENT OVER HIS OPTIONS AND DECIDED NOT TO REMOVE THE STEM. HE THEN TRIALED THE +2.5 CONSTRAINED HUMERAL LINER AND DEEMED IT STABLE (CAPTURED IN MFR# 1038671-2023-01269). NO PIECES OF DEICE FELL INTO THE WOUND SITE. THERE WAS A 5-15 MIN DELAY, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821870 ↗
• InjuryJul 8, 2025Structural Problem; Detachment of Device or Device Component; Structural Problem; Detachment of Device or Device Component

  AS REPORTED BY AN EQUINOXE SHOULDER CLINICAL STUDY, APPROXIMATELY 48 MONTHS POST INITIAL RIGHT SIDE REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT REPORTED SITTING AND REACHING OUT AND THEN EXPERIENCED SUDDEN PAIN. SUBSEQUENTLY, 6 DAYS AFTER THE ONSET OF THE PAIN, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION PROCEDURE. POST OPERATIVELY IT WAS NOTED TO BE HUMERAL TRAY DISASSOCIATION. PATIENT WAS REVISED WITH STANDARD HUMERAL STEM, TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22437449 ↗
• InjuryMay 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 43 MONTHS POST RIGHT TOTAL SHOULDER ARTHROPLASTY; THE PATIENT UNDERWENT A REVISION PROCEDURE. INTRAOPERATIVELY, THE SURGEON OBSERVED THE POLYETHYLENE COMPONENT WAS DISASSEMBLED, CAUSING THE TRAY AND SPHERE TO ARTICULATE TO THE POINT OF WEARING THROUGH THE TRAY CAUSING METALLOSIS. IT WAS NOTED THAT THE PARTS, PIECES AND FRAGMENTS WERE REMOVED FROM THE PATIENT'S WOUND SITE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. THERE WERE NO MEDICAL OR OPERATIVE REPORTS PROVIDED. POST OPERATIVE PHOTOS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 22045066 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 10 MONTHS AND 6 DAYS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT CAME IN TO THE CLINIC AND DESCRIBED A POP SENSATION WHEN REACHING BEHIND THEIR BACK. X-RAY SHOWED A DISSOCIATED TRAY. THE TORQUE SCREW MANAGED TO BACK OUT AND THE TRAY DISSOCIATED FROM THE STEM. A REVISION WAS PERFORMED AND THE STEM WAS EXTRACTED AND A NEW ONE IMPLANTED. A +10 TRAY WAS USED, AND A 38MM POLY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21994377 ↗
• InjuryMay 7, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS AND 7 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT DISLOCATED THEIR SHOULDER AND WORE THE HUMERAL TRAY AS IT RUBBED AGAINST THE GLENOSPHERE. THE SURGEON REMOVED THE GLENOSPHERE AND ALL HUMERAL COMPONENTS BEFORE RE-IMPLANTING ANOTHER EXACTECH PROSTHESIS. PHOTOS PROVIDED SHOWED WEAR OF THE HUMERAL LINER, TRAY, AND GLENOSPHERE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IT WAS IDENTIFIED DURING INVESTIGATION THAT THE EQUINOXE REVERSE TORQUE DEFINING SCREW SHOWED PROSTHESIS WEAR.

  Patient problems: Joint Dislocation

  MAUDE report 21978679 ↗
• InjuryMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, APPROXIMATELY 5 YEARS LATER THE PATIENT NOTED FEELING A PINCH IN THEIR LEFT SHOULDER FOLLOWED BY INTENSE PAIN AND INABILITY TO RAISE THEIR ARM. THE PATIENT WENT TO THE EMERGENCY ROOM AND DISCOVERED THE HUMERAL TRAY HAD DETACHED FROM THE HUMERAL STEM. THE PATIENT NOTED THEY DID NOT EXPERIENCE ANY FORM OF TRAUMA TO THE PROSTHESIS. REVISION SURGERY HAS BEEN SCHEDULED. NO FURTHER PATIENT IMPACT WAS PROVIDED. NO ADDITIONAL IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21978495 ↗
• InjuryApr 30, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 3 YEARS 4 MONTHS POST OPERATION. SUBSEQUENTLY, THE HUMERAL TRAY DETACHED FROM THE HUMERAL STEM. THE PATIENT'S PROSTHESIS WAS NOT ARTICULATING AS INTENDED. SURGEON REMOVED, THE TRAY, LINER, TORQUE SCREW, GLENOSPHERE LOCKING SCREW, AND GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 21939734 ↗
• InjuryMar 7, 2025Detachment of Device or Device Component; Misassembly by Users; Detachment of Device or Device Component; Misassembly by Users

  AS REPORTED, APPROXIMATELY 4 YEARS AND 5 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT EXPERIENCED A FALL, RESULTING IN THE DISASSOCIATION OF THE HUMERAL TRAY AND LINER FROM THE HUMERAL STEM COMPONENT. UPON VIEWING RELEVANT X-RAYS AND CT SCANS, IT APPEARED THE TORQUE DEFINING SCREW WAS INTACT AND UNDAMAGED FROM THE FALL, SUGGESTING THE SCREW HAD BEEN IMPROPERLY TIGHTENED DURING THE PRIMARY SURGERY, AND RESULTINGLY BACKED OUT OVER TIME. SUBSEQUENTLY, WHEN THE PATIENT EXPERIENCED THE FALL, THE MORSE TAPER HOLDING THE HUMERAL TRAY AND STEM TOGETHER DISENGAGED, CAUSING THE DISSOCIATION. THIS WAS CORRELATED BY THE SURGEON. LIKE FOR LIKE REPLACEMENTS WERE IMPLANTED FOR ADAPTER TRAY, TORQUE DEFINING SCREW, LINER AND GLENOSPHERE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Fall

  MAUDE report 21551684 ↗
• InjuryFeb 18, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT'S POLY DISSOCIATED AT AN UNKNOWN POINT, CAUSE UNKNOWN. AFTER DISSECTION, IT WAS NOTED THAT THE MOTION OF THE GLENOSPHERE WITHOUT A POLY IN PLACE HAD WORN AWAY THE HUMERAL TRAY AND LOCKING SCREW. ALL COMPONENTS ABOVE WERE REMOVED AND REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21402518 ↗
• InjuryJan 23, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  AS REPORTED, APPROXIMATELY 1 YEAR AND 11 MONTHS POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT REACHED FOR SOMETHING AND FELT THEIR SHOULDER WAS "OFF". THE PATIENT PRESENTED TO THE CLINIC AND X-RAYS SHOWED THE TRAY HAD DISSOCIATED FROM THE STEM RESULTING IN A REVISION OF THE SHOULDER. THE TRAY AND LINER TOGETHER HAD DISSOCIATED FROM THE STEM, WITH THE TORQUE SCREW VISIBLE IN THE TRAY. THE SCREW HAD NOT BROKEN OFF IN THE STEM AND ALL THREADS COULD BE VISUALIZED IN THE STEM. AFTER SEPARATING THE LINER FROM THE TRAY, IT APPEARED THE TORQUE SCREW FAILED AND BACKED OUT OF THE STEM COMPLETELY, CAUSING THE TRAY AND LINER TO DISSOCIATE FROM THE STEM AND SHIFT SUPERIOR. THE STEM WAS STILL WELL FIXED AND THE SURGEON DETERMINED THE THREADS WERE NOT DAMAGED. THE SURGEON RETAINED THE STEM AND SWAPPED OUT THE GLENOSPHERE, TRAY AND LINER. THE PATIENT WAS REVISED TO A 46 EXPANDED SPHERE, NEW LOCKING SCREW, UPDATED 10MM TRAY, NEW TORQUE SCREW, AND A 46MM 2.5MM LINER. NO PARTS OR PIECES OF THE NEW IMPLANTS FELL INTO THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21219458 ↗
• InjuryJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS 1 OF 2 REPORTS FOR THIS EVENT. SEE MDR# 1038671-2025-00294.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 21173016 ↗
• InjuryJan 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS PATIENTS RIGHT SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 5 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. TRAY DISASSEMBLED FROM STEM AND SCREW BROKE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 21145972 ↗
• InjuryNov 7, 2024Separation Failure; Separation Failure

  AS REPORTED, APPROXIMATELY 1 MONTH AND 9 DAYS POST THE FIRST REVISION SURGERY, THE PATIENT PRESENTED BACK WITH CONTINUED ISSUES WITH INSTABILITY AND PAIN. THE PATIENT UNDERWENT A SECOND REVISION. THE SURGEON HAD ISSUES WITH BEING ABLE TO GET THE TORQUE SCREW OUT OF THE HUMERAL STEM AND TRAY. IT WAS NOT FULLY RELEASED FROM THE STEM, CAUSING THE HUMERAL TRAY TO SPIN CIRCUMFERENTIALLY AROUND THE STEM. THE SURGEON REPLACED THE GLENOSPHERE WITH A LATERALIZED ONE, KEPT THE TRAY AS IT WOULD NOT RELEASE FROM THE STEM, AND IMPLANTED A CONSTRAINED LINER. THERE WAS A 5-15 MINUTE DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE DELAY. THE SURGEON FELT HE GOT A STABLE CONSTRUCT WITH THE IMPLANTS THAT HE WAS ABLE TO EXCHANGE. HE WOULD HAVE LIKED TO BE ABLE TO RELEASE THE HUMERAL TRAY FROM THE HUMERAL STEM AND SPENT SOME TIME TRYING TO DISENGAGE THE IMPLANTS HOWEVER WAS NOT ABLE TO GET THEM TO DISENGAGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20633059 ↗
• InjurySep 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS 88Y/O MALE PATIENT WAS REVISED APPROXIMATELY 3 YEARS 6 MONTHS POST OP. TORQUE SCREW BROKE AND POLY WORE. JOINT LOOKED OVERSTUFFED, BASEPLATE PUT IN TOO HIGH. SURGEON HEAVILY DEBRIDED AND USED RONGEUR TO REMOVE. SURGEON REMOVED AND CONVERTED TO COMPETITORS REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: IMPLANTS WERE LEFT AT THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 20239939 ↗
• InjuryAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 77 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE TORQUE SCREW BACKED OUT OF THE STEM COMPLETELY. THE TRAY DISSOCIATED FROM THE STEM. A NEW TRAY WITH TORQUE SCREW WAS PLACED BY THE SURGEON, AS WELL AS A NEW POLY AND GLENOSPHERE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE DEVICE IS AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19955930 ↗

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-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-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-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-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-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-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-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.