Equinoxe 310-01-50 (UDI 10885862083890)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862083890), received between Mar 16, 2023 and Jul 22, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 7 YEARS POST INITIAL OPERATION. THE POLY HAD BEEN WORN AND BROKEN INTO PIECES. THERE WAS A MAIN FRACTURE ACROSS THE MIDDLE OF POLY. THE PERIPHERAL PEGS AND POLY WERE REMOVED WITH FORCEPS. THE MIDDLE OF THE CENTER CAGE WAS STILL IN THE BONE AND SOLIDLY FIXED. THE REMOVAL TOOL WAS USED TO EXTRACT IN A SINGLE PIECE. THE PATIENT'S ROTATOR CUFF WAS FULLY INTACT. THE PRESERVE STEM WAS EXPOSED PROXIMALLY DUE TO LYTIC LESIONS, BUT WAS NOTED TO BE WELL FIXED. OSTEOLYSIS WAS ALSO OBSERVED ON THE GLENOID SIDE WHICH REQUIRED BONE GRAFTING. PATIENT WAS REVISED FROM AN ANATOMIC TO REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 22563799 ↗
• InjuryJul 15, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL RIGHT TSA, THIS FEMALE PATIENT WAS REVISED DUE TO SIGNIFICANT METALOSIS WITH HUMERAL HEAD SCRATCHING AGAINST CENTRAL CAGE OF GLENOID. THE PERIPHERAL PEGS WERE STILL CONNECTED TO POLY BUT WAS MIGRATED AWAY FROM ORIGINAL POSITION. THE CENTRAL CAGE REMAINED IN ITS ORIGINAL POSITION WELL FIXED. GLENOID WAS BONE GRAFTED AND CONVERTED TO ARTHREX BASEPLATE AND GLENOSPHERE. THE HUMERAL HEAD AND REPLICATOR WERE REMOVED. A +0 TRAY AND 36 +0 LINER WAS IMPLANTED WITH GOOD STABILITY AND ROM. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS NOT AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Pain

  MAUDE report 22506050 ↗
• InjuryJul 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN SECONDARY TO POLY DISASSOCIATION. AS A RESULT, APPROXIMATELY SEVEN YEARS AND SEVEN MONTHS 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 2 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22420903 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 7 YEARS AFTER INITIAL LEFT TSA, THE PATIENT WAS REVISED DUE TO FAILURE OF THE CAGE GLENOID, THE PEGS HAD DISSOCIATED FROM THE POLY. THE PATIENT HAD OSTEOLYSIS, SIGNS OF METALLOSIS AND SIGNIFICANT BONE LOSS. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE PATIENT WAS REVISED TO A DJO GLENOID AND EXACTECH HUMERAL COMPONENTS. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NO LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS PROVIDED. PRODUCT NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 19716074 ↗
• InjurySep 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TSA, THE 61 Y/O MALE PATIENT DEVELOPED PAIN AND X RAY SHOWED HUMERAL LOOSENING. PATIENT HAD A REVISION SURGERY ON (B)(6) 2023. PER CLINICAL REPORT, THE REPORTED EVENT IS POSSIBLY RELATED TO THE DEVICE AND TO THE PROCEDURE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17814826 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51 YEAR-OLD MALE PATIENT WHO HAD AN INITIAL LEFT SHOULDER ARTHROPLASTY ON (B)(6) 2022, WAS REVISED ON (B)(6) 2023, APPROXIMATELY 10 MONTHS POST THE INITIAL PROCEDURE. THE REVISION PROCEDURE WAS FOR FAILED ROTATOR CUFF IN L) HEMI-ARTHROPLASTY, PERFORMED FOR PROXIMAL HUMERAL FRACTURE IN 2022. ALL COMPONENTS WERE REVISED AND CONVERTED TO A REVERSE TOTAL SHOULDER REPLACEMENT USING EQUINOXE SYSTEM. NO SURGICAL DELAYS REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. THE IMPLANTS WERE REQUIRED FOR COLLECTION OF INFECTED MATERIALS AND WERE SENT TO HOSPITAL PATHOLOGY. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthropathy

  MAUDE report 16556690 ↗

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-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-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-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-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-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