Equinoxe 300-01-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862283009), received between May 26, 2023 and Apr 14, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A CLINICAL STUDY, THAT A PATIENT, WHO HAD A RTSA, UNDERWENT A REVISION PROCEDURE. THE STUDY INDICATED A POSSIBLE LOOSE STEM. ASEPTIC HUMERAL LOOSENING. UNLIKELY RELATED TO THE DEVICE OR THE PROCEDURE. THE SURGEON REMOVED THE STANDARD HUMERAL STEM. THE OUTCOME STATES RESOLVED. NO FURTHER INFORMATION.

  Patient problems: Aseptic loosening

  MAUDE report 24880290 ↗
• 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 20632441 ↗
• InjuryJun 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS HUMERAL STEM LOOSENING. PATIENT REVISED TO EXACTECH DEVICES. REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE, THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19623790 ↗
• InjuryDec 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6)2023. THE PATIENT PRESENTED ON (B)(6) 2023 WITH ASEPTIC HUMERAL LOOSENING. PATIENT REPORTS SIGNIFICANT PAIN. X-RAYS SHOW LUCENCY AROUND CEMENT OF THE HUMERUS, LIKELY INDICATING LOOSENING OF HARDWARE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS CONTINUING. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18419169 ↗
• InjuryOct 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A FEMALE PATIENT. INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON SEPTEMBER 28, 2023, APPROXIMATELY 5 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD ASEPTIC LOOSENING OF THE HUMERAL STEM. THE SURGEON CEMENTED IN A SIZE 10 PRIMARY HUMERAL STEM WITH +15 HUMERAL TRAY. NO DEVICE IMAGES OR X-RAYS PROVIDED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE SURGEON WANTED THEM. NO FURTHER INFORMATION.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17926247 ↗
• InjurySep 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY TWO YEARS POST INITIAL TSA, THE 66 Y/O PATIENT CAME IN FOR FOLLOW UP AND SHOWED SIGNS OF ASEPTIC HUMERAL LOOSENING. PATIENT HAD A REVISION ON (B)(6) 2022. PATIENT'S STANDARD HUMERAL STEM, HUMERAL TRAY AND HUMERAL LINER WERE REVISED. PER CLINICAL REPORT, THE REPORTED EVENT IS DEFINITELY RELATED TO THE DEVICE AND PROCEDURE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17751612 ↗
• InjuryMay 26, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THIS 63 Y/O MALE PATIENT HAD A HUMERAL FRACTURE, AN INTRAOP CALCAR FRACTURE IN THE SHOULDER. SURGEON USED ORIF WITH CABLE DURING SURGERY. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONTINUING. DEVICE IS NOT RETURNING, CLINICAL STUDY.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17011478 ↗

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, 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-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-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-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-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-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