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Equinoxe 320-42-03Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Exactech Equinoxe reverse shoulder implant has 86 adverse event reports: 86 injuries and no deaths. The reports mostly describe the polyethylene liner coming loose or dislodging from the metal tray, causing dislocations and revision surgeries. There are 2 open recalls: one for liners whose articular surface sits outside the labeled size specification, and one for liners and glenoids packaged without an oxygen barrier layer.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
87
Deaths reported
0
Injuries reported
87
Recalls naming it
2

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10885862086709), received between Oct 15, 2019 and Sep 30, 2026 — classified as 87 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (40 reports).

2 FDA recall records name this device's identifier, 2 still open.

11 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 3 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 5 reportsMay 2024: 2 reportsJun 2024: 3 reportsJul 2024: 0 reportsAug 2024: 2 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 3 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 2 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 3 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 3 reportsSep 2025: 1 reportsOct 2025: 2 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 2 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 15, 2025Open, Classified

    Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

    Z-2561-2025 · Root cause: Process design · FDA record ↗

  2. Mar 6, 2024Open, Classified

    The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

    Z-1422-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component40
  • Device Dislodged or Dislocated38
  • Adverse Event Without Identified Device or Use Problem14
  • Naturally Worn12
  • Unstable7
  • Mechanical Problem3
  • Insufficient Device Problem Information2
  • Loosening of Implant Not Related to Bone-Ingrowth2

Patient problems

  • Joint Dislocation30
  • Failure of Implant26
  • Insufficient Information20
  • Joint Laxity10
  • Pain10
  • Bacterial Infection6
  • Metal Related Pathology5
  • Loss of Range of Motion3

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Detachment of Device or Device Component

    As reported, approximately 7 years and 7 months post the initial right total shoulder arthroplasty, the patient was revised due to the poly disengaging and the shoulder dislocating. 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: Joint Dislocation

    MAUDE report 50945327 ↗
  • InjurySep 14, 2026Device Dislodged or Dislocated

    It was reported that the patient underwent a right shoulder replacement. Subsequently, they experienced a dislocation. The surgeon revised the implant by exchanging the existing liner for a constrained liner. The patient was last known to be in stable condition following the event. No further information is available.

    Patient problems: Joint Dislocation

    MAUDE report 50755430 ↗
  • InjuryAug 31, 2026Device Dislodged or Dislocated

    As reported, the patient underwent an initial left reverse total shoulder arthroplasty. Subsequently, the patient was revised due to dislocation with an unknown cause. The poly looked to be in decent shape. A new 42 +2.5 constrained liner was used with no issue. No further information obtained.

    Patient problems: Joint Dislocation

    MAUDE report 50531260 ↗
  • InjuryAug 31, 2026Insufficient Device Problem Information

    As reported, the patient underwent an initial reverse total shoulder arthroplasty. Subsequently, the patient underwent a revision to replace the humeral liner for an unknown reason. No further information obtained.

    Patient problems: Insufficient Information

    MAUDE report 50531112 ↗
  • InjuryJun 16, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT A PATIENT, WHO HAD RIGHT RTSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN. LINER DISASSOCIATION INDICATED. THE LINER WAS REVISED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN DUE TO THE HOSPITALS CHAIN OF COMMAND. A DEVICE IMAGE OF THE HUMERAL LINER WAS PROVIDED. PROSTHESIS WEAR WAS OBSERVED IN THE IMAGE. NO FURTHER INFORMATION.

    Patient problems: Pain

    MAUDE report 25527218 ↗
  • InjuryJun 1, 2026Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

    IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS UNSTABLE AND WAS DISLOCATING REQUIRING THE REVISION TO REGAIN THEIR JOINT STABILITY. DURING THE SURGERY, THERE WERE CLEAR SIGNS OF METALLOSIS AND BLACK TISSUE. THE POLY WAS EASILY REMOVED, AND THE SURGEON STATED THAT THE POLY WASN'T REALLY LOCKED INTO THE HUMERAL TRAY BUT WAS JUST SITTING ON TOP OF IT. THE SURGEON REMOVED THE 42MM +2.5 POLY AND THE +0 HUMERAL TRAY AND TORQUE SCREW AS WELL AS THE 42MM GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THE SURGEON KEPT THE 7MM PRESERVE STEM IMPLANTED AS IT WAS WELL FIXED AND ALSO KEPT THE GLENOID BASEPLATE IMPLANTED AND THE 3 PERIPHERAL SCREWS. TO INCREASE JOINT STABILITY, THE SURGEON RE-IMPLANTED A 42MM +4 LAT. GLENOSPHERE AND LOCKING SCREW ON THE GLENOID SIDE AND ON THE HUMERAL SIDE, HE IMPLANTED A +5MM HUMERAL TRAY AND TORQUE SCREW WITH A 42MM +0 CONSTRAINED LINER. THE PATIENT WAS STABLE WITH THESE IMPLANTS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL W

    Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology

    MAUDE report 25355781 ↗
  • InjuryApr 22, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE DUE TO POLYETHYLENE LINER DISASSOCIATION. THE LINER SEPARATED FROM THE HUMERAL TRAY. THEY WERE REVISED TO 42+4 LATERALIZED GLENOSPHERE, REVERSE SHOULDER GLENOSPHERE LOCKING SCREW AND A 42+2.5MM CONSTRAINED HUMERAL LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Patient problems: Insufficient Information

    MAUDE report 24955773 ↗
  • InjuryMar 30, 2026Detachment of Device or Device Component

    AS REPORTED, APPROXIMATELY 4 YEARS AND 1 MONTH POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO POLY DISASSOCIATION. THE POLY WAS RECALLED. 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: Pain

    MAUDE report 24712338 ↗
  • InjuryMar 16, 2026Detachment of Device or Device Component

    THE PATIENT PREVIOUSLY UNDERWENT A RIGHT SHOULDER REPLACEMENT. SUBSEQUENTLY, THE POLYETHYLENE LINER BECAME DISLODGED. THE SURGEON PERFORMED A REVISION PROCEDURE AND REPLACED THE DISLODGED LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 24608198 ↗
  • InjuryJan 15, 2026Detachment of Device or Device Component

    AS REPORTED, APPROXIMATELY 8 YEARS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A DISASSOCIATED 42+0 LINER. THE PATIENT WAS REVISED TO A 42+2.5 CONSTRAINED LINER AND FROM A 42 GLENOSPHERE TO A 42+4. 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 24078559 ↗
  • InjuryDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY WHILE MOVING A LAWN MOWER. AS A RESULT, THEY WERE REVISED DUE TO DISASSOCIATION OF THE POLYETHYLENE. THE SURGEON REVISED THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Joint Laxity

    MAUDE report 23906614 ↗
  • InjuryOct 28, 2025Mechanical Problem; Detachment of Device or Device Component; Naturally Worn; Mechanical Problem; Detachment of Device or Device Component; Naturally Worn

    AS REPORTED, APPROXIMATELY 14 YEARS AND 2 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT CAME IN WITH A RIGHT LOOSE POLY. THE PATIENT WAS REVISED AND THE GLENOSPHERE, HUMERAL TRAY, TORQUE SCREW AND CONSTRAINED LINER WERE EXCHANGED. PHOTOS PROVIDED APPEAR TO SHOW WEAR OF THE 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.

    Patient problems: Loss of Range of Motion

    MAUDE report 23407983 ↗
  • InjuryOct 27, 2025Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 2 YEARS AND 7 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS BROUGHT BACK WITH SHOULDER INSTABILITY. THE SHOULDER WAS DISLOCATED. PHOTOS PROVIDED SHOW WEAR OF THE LINER. THE POLY LINER, TORQUE SCREW AND HUMERAL TRAY WERE REMOVED. THE SURGEON OPTED TO TRIAL WITH A +15 SETUP. THIS WAS FOUND TO BE WELL STABLE. A NEW +15 TRAY, TORQUE SCREW AND 42 +0 CONSTRAINED LINER WERE IMPLANTED. 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: Joint Dislocation; Joint Laxity

    MAUDE report 23391891 ↗
  • InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER REPLACEMENT WAS REVISED. THE PATIENT STATED THEY WERE EXERCISING WHEN THE LINER DISLOCATED. THE SURGEON REPLACED ONLY THE LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Joint Dislocation

    MAUDE report 22945326 ↗
  • InjuryAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 2 YEARS AND 2 MONTHS POST INITIAL OPERATION. THE PATIENT EXPERIENCED A DISPLACED POLY LINER FROM A DISLOCATION. SURGEON EXCHANGED THE GLENOSPHERE AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Joint Dislocation

    MAUDE report 22889862 ↗
  • InjuryAug 22, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED MECHANICAL LOOSENING OF OTHER INTERNAL PROSTHETIC JOINT. AS A RESULT, APPROXIMATELY 2 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: Aseptic loosening; Muscle/Tendon Damage

    MAUDE report 22874634 ↗
  • InjuryAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED IN A SHOULDER CLINICAL STUDY APPROXIMATELY 7 MONTHS AFTER A LEFT SHOULDER REPLACEMENT SURGERY A PATIENT REPORTED HE DISLOCATED HIS SHOULDER. X-RAYS WERE OBTAINED AND REVEALED DISASSOCIATION OF THE POLYETHYLENE LINER. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Joint Dislocation

    MAUDE report 22743227 ↗
  • InjuryJul 29, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN SECONDARY TO POLYETHYLENE DISASSOCIATION. AS A RESULT, APPROXIMATELY ELEVEN YEARS AND ONE-MONTH POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

    Patient problems: Pain

    MAUDE report 22649416 ↗
  • InjuryJul 8, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Noise, Audible; Detachment of Device or Device Component; Device Dislodged or Dislocated; 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 22436318 ↗
  • InjuryMay 22, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

    AS REPORTED, APPROXIMATELY 5 YEARS AND 1 MONTH POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR/FRACTURE. THE LINER AND GLENOSPHERE WERE EXCHANGED. PHOTOS PROVIDED INDICATE THERE MAY BE METAL-ON-METAL WEAR BETWEEN THE GLENOSPHERE AND TRAY. 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: Bone Fracture(s); Metal Related Pathology

    MAUDE report 22069422 ↗
  • InjuryMay 16, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S RIGHT SHOULDER REVISED DUE TO PAIN AND A LOOSE STEM. REVERSE IMPLANTS WERE ALL REMOVED, MINUS THE BASEPLATE BECAUSE IT WAS WELL FIXED, AND REVISED TO NEW SAME COMPANY IMPLANTS. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

    Patient problems: Pain

    MAUDE report 22037776 ↗
  • InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. THE PATIENT REACHED OVERHEAD AND FELT A "SHIFT" IN THEIR RIGHT SHOULDER. AS A RESULT, APPROXIMATELY 1.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 22015040 ↗
  • InjuryMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 8 YEARS POST INITIAL OPERATION. SURGEON REVISED AN EQUINOXE REVERSE SHOULDER DUE TO A DISASSOCIATED 42 LINER. HE REMOVED A 42 GLENOSPHERE, 42+0 LINER AND +0 HUMERAL TRAY. HE REPLACED THEM WITH A 42+4 GLENOSPHERE, 42+0 LINER AND A +15 HUMERAL TRAY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Patient problems: Insufficient Information

    MAUDE report 21689611 ↗
  • InjuryFeb 20, 2025Mechanical Problem; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

    AS REPORTED, APPROXIMATELY 4 YEARS AND 11 MONTHS POST THE PATIENT'S INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS BROUGHT BACK WITH LIMITED RANGE OF MOTION. THE POLY WAS FOUND TO BE LOOSE FROM THE HUMERAL TRAY. THE POLY AND HUMERAL TRAY WERE REMOVED. IMPLANTS OF THE SAME SIZE WERE THEN IMPLANTED. 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: Loss of Range of Motion

    MAUDE report 21429046 ↗
  • InjuryFeb 20, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

    AS REPORTED, THE SURGEON STATES THE PATIENT FELL AND FRACTURED THEIR ELBOW ON THE IMPLANT SIDE. IT WAS BELIEVED TO BE TREATED NON-OPERATIVELY, BUT THE SURGEON BELIEVED BECAUSE OF THE FALL THE PATIENT POINT-LOADED ON THE POLY AND IT DISLOCATED FROM THE TRAY. THE PATIENT WAS EXPOSED AND THE LINER WAS IN FACT DISLOCATED AND LOCATED POSTERIOR/SUPERIOR OF THE HUMERAL TRAY. THERE WAS SOME WEAR ON THE LINER AND OF THE TRAY ON THE INFERIOR PORTION LIKELY DUE TO RUBBING ON THE SPHERE. THE GLENOID COMPONENTS WERE INTACT AND LEFT ALONE. THE TORQUE SCREW AND TRAY WERE REMOVED WITH THE LINER, AND REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Patient problems: Fall

    MAUDE report 21429031 ↗

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-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-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-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-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-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-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.

Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.