Equinoxe 300-01-13Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Exactech Equinoxe shoulder implant replaces part of the shoulder joint. Reports mostly describe the humeral stem coming loose months or years after surgery and needing another operation to replace it, along with fractures around the implant and some dislocations with wear. There are 25 reports naming its identifier, with no deaths and 25 injuries. No recalls name this device.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885862079329), received between Jun 18, 2019 and Nov 19, 2025 — classified as 25 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 reports).
10 other recalls cover devices cleared under the same FDA submission (K042021); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Loosening of Implant Not Related to Bone-Ingrowth7
- Fracture4
- Device Dislodged or Dislocated3
- Loss of Osseointegration1
- Migration1
- Naturally Worn1
Patient problems
- Bone Fracture(s)10
- Failure of Implant5
- Periprosthetic fracture5
- Aseptic loosening3
- Pain3
- Unspecified Infection3
- Bacterial Infection2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY 1 YEAR AND 8 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE HUMERAL STEM WAS FOUND TO BE LOOSE AND THE PATIENT'S HUMERAL SIDE WAS REVISED TO COMPETITOR DEVICES. 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: Aseptic loosening
MAUDE report 23593456 ↗InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED HUMERAL STEM LOOSENING. AS A RESULT, APPROXIMATELY SIX YEARS 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 3 FOR THIS EVENT/PATIENT.
Patient problems: Aseptic loosening
MAUDE report 23586914 ↗InjuryAug 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY 4 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT SHOWED UP IN THE CLINIC WITH HUMERAL PAIN. THE PATIENT SHOWED SIGNS OF HUMERAL STEM LOOSENING AND WAS CONVERTED FROM A PRIMARY SHOULDER TO A COMPETITOR REVERSE TOTAL SHOULDER CONSTRUCT. PHOTOS PROVIDED SHOW WEAR OF THE GLENOID COMPONENT. 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: Implant Pain; Inadequate Osseointegration; Pain
MAUDE report 22698094 ↗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 HUMERAL STEM SHOWED PROSTHESIS WEAR.
Patient problems: Joint Dislocation
MAUDE report 21978642 ↗InjuryMar 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY ONE YEAR AND 7 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH LOOSENING OF THE HUMERAL STEM AND WAS REVISED. THE HUMERAL STEM, ADAPTOR PLATE AND HUMERAL LINER WERE REPLACED. 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 21501325 ↗InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY 2 WEEKS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS COMPLAINING OF PAIN. ON X-RAY THERE WAS A CALCAR FRACTURE, BUT WAS STABLE AFTER OPENING UP. THE INFECTION MARKERS WERE UP SO A POLY EXCHANGE AND A WASHOUT WAS DONE WITH SAMPLES TAKEN. 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); Pain; Unspecified Infection
MAUDE report 21457886 ↗InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
APPROXIMATELY 1 YEAR 5 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT, THE PATIENT SUFFERED A PERIPROSTHETIC HUMERAL FRACTURE AND NEEDED PLATING AND STEM REPLACEMENT. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF THE DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Bone Fracture(s)
MAUDE report 19728971 ↗InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 68-YEAR-OLD NON-HISPANIC WHITE MALE HAD A LEFT TSA ON (B)(6) 2009. THE PATIENT PRESENTED WITH HUMERAL FRACTURE INTRA-OPERATIVELY ON (B)(6) 2024. PROXIMAL HUMERAL FRACTURE WITH REMOVAL OF STEM. THE ACTION TAKEN WAS OTHER ¿ PERFORMED ORIF OF PROX HUMERUS ON (B)(6) 2024 AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2024. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 19212739 ↗InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 79-YEAR-OLD NON-HISPANIC WHITE MALE HAD A RIGHT TSA ON (B)(6) 2024. INTRA-OPERATIVELY ON (B)(6) 2024, PATIENT EXPERIENCE A CALCAR SPLIT WHILE IMPACTING HUMERAL STEM. THE PATIENT UNDERWENT THE ACTION OF 2.0 BEADED CABLE ON (B)(6) 2024 AND THE OUTCOME OF THIS EVENT IS CONSIDERED TO BE RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 19093744 ↗InjuryMar 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 62-YEAR-OLD FEMALE PATIENT HAD A RIGHT TSA ON (B)(6) 2018. THE PATIENT PRESENTED WITH DISLOCATION- ANTERIOR DISLOCATION, 0 YEAR(S) AND 1 MONTH(S) POST PROCEDURE ON (B)(6) 2018. A POST OPERATIVE EVENT WAS REPORTED ON (B)(6) 2018 AND CAPTURED CASE (B)(4). THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE REPORT INDICATES THAT THE ACTION TAKEN IS REVISION BY CLOSED REDUCTION ON 7/18/2018. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.
Patient problems: Joint Dislocation
MAUDE report 18886686 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A LEFT TSA ON (B)(6) 2019 AND PRESENTED WITH DEEP INFECTION, ON (B)(6) 2022. PATIENT WAS SEEN ON (B)(6) 2022. DESCRIBES SIGNIFICANT PAIN SHOULDER WHILE ATTEMPTING TO LIFT A 50LBS. BAG 6 WEEKS PRIOR TO VISIT. WORK UP W/ CT INDICATED RCT. REVISION WAS RECOMMENDED TO CONVERT TO RTSA. PATIENT DELAYED SURGERY FOR OVER A YEAR. INTRA-OP FINDINGS SHOWED AN INTACT RC. SIGNIFICANT SYNOVITIS WAS ENCOUNTERED, AND A DEEP INFECTION WAS SUSPECTED. A STAGE REVISION WAS CARRIED OUT BY PLACING A SPACER. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2024. THE ACTION TAKEN WAS REVISION ON WITH THE REMOVAL OF THE STANDARD HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, GLENOID. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.
Patient problems: Bacterial Infection; Implant Pain; Inflammation; Unspecified Infection
MAUDE report 18861547 ↗InjuryOct 2, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT PRESENTED - IN TAKING OFF THE HUMERAL HEAD, THE STEM BECAME LOOSE AND THE PORTION PROXIMALLY WHICH HAD STRESS SHIELDING BROKE FREE FROM SHAFT. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2023.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 17852550 ↗InjuryOct 2, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2020. THE PATIENT PRESENTED HAD SMALL, NON-PROPAGATING SPLIT WITHIN GREATER TUBEROSITY UPON REMOVAL OF HUMERAL TRIAL STEM. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE, POSSIBLY RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2020.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 17851407 ↗InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY 6 MONTHS POST OP INITIAL RIGHT TSA, THIS 56 Y/O MALE PATIENT WAS REVISED DUE TO INSTABILITY. SECOND STAGE PROCESS. EVERYTHING WAS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING EVENT. PRODUCT NOT RETURNING: DISPOSED AT THE HOSPITAL. UNABLE TO OBTAIN IMAGES OR X-RAYS.
Patient problems: Failure of Implant
MAUDE report 17681955 ↗InjuryAug 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED VIA A EQUINOXE SHOULDER STUDY, THAT A 63 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE DUE TO ASEPTIC HUMERAL LOOSENING. DATE OF ONSET,(B)(6) 2023. THE STANDARD HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID WERE REMOVED. THE SUBSCAPULARIS WAS REPAIRED, AND A BICEPS TENODESIS WAS PERFORMED. THE STUDY STATES THE EVENT WAS DEFINITELY RELATED TO THE DEVICES AND THE PROCEDURE. THE OUTCOME INDICATES CONTINUING. NO DEVICE RETURNS ANTICIPATED DUE TO CLINICAL STUDY GUIDELINES. NO FURTHER INFORMATION.
Patient problems: Insufficient Information
MAUDE report 17643681 ↗InjuryAug 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 83 Y/O FEMALE PATIENT EXPERIENCE A DIFFICULT DISLOCATION GREATER TUBEROSITY FRACTURED, REMAINING UN-DISPLACED. PATIENT CAME TO 6 MONTH CHECK UP AND IS HAPPY WITH HER SHOULDER REPLACEMENT. PER CLINICAL STUDY REPORT THE REPORTED EVENT IS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.
Patient problems: Bone Fracture(s)
MAUDE report 17628951 ↗InjuryJun 19, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT WAS REVISED TO A FRACTURE PLATFORM STEM ON (B)(6) 2023 DUE TO A BONE FRACTURE AND STEM DISLOCATION. 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: Failure of Implant; Periprosthetic fracture
MAUDE report 17159823 ↗InjuryNov 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY 6 YEARS POST OP THE INITIAL LEFT TSA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO STEM LOOSENING. PATIENT'S HUMERAL COMPONENTS AND GLENOSPHERE WERE REMOVED AND EXCHANGED DUE TO THE STEM BEING LOOSE. PATIENT WAS REVISED TO A LONG STEM 10 X 200MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, HOSPITAL POLICY.
Patient problems: Aseptic loosening; Failure of Implant
MAUDE report 15708086 ↗InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY 1 YEAR POST OP THE INITIAL RIGHT TSA, THIS MALE PATIENT WAS REVISED DUE TO AN INFECTION. PATIENT HAD AN INFECTED SHOULDER AND THE SURGEON OPTED TO REMOVE ALL IMPLANTS, WASH OUT AND REPLACE WITH A CEMENT SPACER. THIS IS A SECOND STAGE REVISION AFTER AND INITIAL WASH OUT AND HUMERAL LINER AND GLENOSPHERE EXCHANGE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Bacterial Infection
MAUDE report 14490840 ↗InjuryApr 7, 2022Fracture; Fracture
AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP THE INITIAL TSA, THIS (B)(6) FEMALE PATIENT WAS REVISED DUE A MIDSHAFT HUMERAL FRACTURE. REVISED TO LONG STEM HUMERUS AND ORIF OF PERIPROSTHETIC HUMERAL FRACTURE. REASON FOR REVISION WAS NOT REPORTED. DESCRIPTION INFORMATION OF ADVERSE EVENT IS NOT AVAILABLE. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. DEVICES WILL NOT BE RETUNING.
Patient problems: Bone Fracture(s)
MAUDE report 14042958 ↗InjuryMar 24, 2022Migration; Migration
AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL LEFT TSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO THE STEM BEING SUBSIDED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.
Patient problems: Failure of Implant
MAUDE report 13874422 ↗InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THIS (B)(6) Y/O MALE EXPERIENCED A CRACK IN CALCAR DURING IMPLANT IMPLEMENTATION, NOTED AS AN INTRA-OP RIGHT HUMERAL FRACTURE. THE PLAN POST-PROCEDURE IS SLOW AND CONTROLLED REHABILITATION. THE PATIENT HAS A HISTORY OF RHEUMATORY ARTHRITIS, HYPERTENSION, CHRONIC RENAL FAILURE AND IS ON DIALYSIS. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY RELATED PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.
Patient problems: Bone Fracture(s)
MAUDE report 10727708 ↗InjuryJun 4, 2020Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth
APPROXIMATELY 10 WEEKS POSTOP THE INITIAL LEFT TSA, AN (B)(6) Y/O MALE PATIENT¿S POLY BECAME DISENGAGED IN THE LEFT SHOULDER CAUSING A REVISION. THE SURGEON WANTED TO REVISE THE GLENOSPHERE AS WELL. AS A RESULT, HE ¿REBROKE¿ THE SCREW ON THE TRAY, AND WHEN HE WENT TO DISLODGE THE TRAY FROM THE STEM, THE ENTIRE STEM CAME LOOSE CAUSING A NECESSARY FULL REVISION OF THE HUMERAL SIDE AS WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS AVAILABLE FOR RETURN.
Patient problems: Failure of Implant; Pain
MAUDE report 10118134 ↗InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem
THE ORIGINAL OPERATION WAS DONE ON (B)(6) 2017. IMPLANTS NEED TO BE REMOVED DUE TO INFECTION. A SPACER IS INSERTED.
Patient problems: Unspecified Infection
MAUDE report 8707422 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.
- Z-0535-2026 · Sep 5, 2025 · Open, ClassifiedBrand 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, ClassifiedBrand 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-0537-2026 · Sep 5, 2025 · Open, ClassifiedBrand 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, ClassifiedExactech 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, ClassifiedExactech 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-1404-2024 · Mar 6, 2024 · Open, ClassifiedExactech 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-1403-2024 · Mar 6, 2024 · Open, ClassifiedExactech 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-0884-2021 · Nov 9, 2020 · Open, ClassifiedEquinoxe Humeral Stem, Primary, Press Fit, 11mm
- Z-1459-2015 · Feb 13, 2015 · TerminatedEquinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
- Z-2115-2012 · Jun 15, 2012 · TerminatedEquinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page