Equinoxe 310-01-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862083869), received between Jan 23, 2023 and Apr 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 9, 2026Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND METALLOSIS. AS A RESULT, THE GLENOID SNAPPED IN HALF AND THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 24830257 ↗
• InjuryMar 26, 2026Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED 6 YEARS 4 MONTHS POST OP INITIAL SURGERY. SURGEON REVISED TO REVERSE. A +10 EXT CAGE BASEPLATE WITH A FEMORAL HEAD STRUCTURAL ALLOGRAFT WAS IMPLANTED. WORN AND DAMAGED DEVICE WAS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology

  MAUDE report 24699428 ↗
• InjuryJul 21, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED. ONE PEG AND CAGE ALSO DISSOCIATED AND WERE REMOVED. METALLOSIS WAS SEEN, MOST LIKELY DUE TO THE PEGS/CAGE BEING EXPOSED TO THE HEAD. THE STEM WAS LOOSE AS WELL. EXPLANTED ALL HARDWARE AND REVISED TO AN ANTIBIOTIC SPACER. ALL PARTS/PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A 45 MINUTE SURGICAL DELAY, BUT NO ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 22554554 ↗
• InjuryMar 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED EXCESSIVE WEAR OF IMPLANT COMPONENTS SECONDARY TO DAMAGE OF ARTICULAR SURFACES, AS WELL AS PAIN AND FUNCTIONAL IMPOTENCE. AS A RESULT, APPROXIMATELY 11 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: Pain

  MAUDE report 21647617 ↗
• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SEVERE WEAR AND METALLOSIS ON (B)(6) 2025. NO FURTHER PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 21569123 ↗
• InjuryFeb 3, 2025Naturally Worn; Naturally Worn

  AS REPORTED, IT WAS SUSPECTED THAT THE GLENOID POLYETHYLENE HAD DISSOCIATED. APPROXIMATELY 5 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED AND THE FINDINGS SHOWED THAT THE POLY HAD SEVERE WEAR PATTERNS THAT HAD CAUSED LYSIS AND METALLOSIS. THE SURGEON SAID THERE HAS BEEN NO EVENT TO CAUSE SUCH WEAR. THE PATIENT HAD THE GLENOID REMOVED AND A JUMBO HEMI LEFT IN PLACE. 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: Metal Related Pathology; Osteolysis

  MAUDE report 21293667 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT COMPLAINED OF PAIN IN SHOULDER REGION AFTER SHOULDER PLACEMENT ROTATOR CUFF ARTHROPLASTY. PATIENT WAS SCHEDULED FOR A REVISION OF AN EQUINOXE HEMI ARTHROPLASTY TO CONVERT TO A REVERSE TSA. THE PATIENT WAS CONVERTED TO AN EQUINOXE REVERSE TSA ON (B)(6) 2022. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 5-15 MINS. THERE WERE NO ADVERSE EVENTS AS A RESULT. THE SURGERY TOOK A LITTLE EXTRA TIME FOR THE REMOVAL OF IMPLANTS AND REVISION OF HEMI TO REVERSE TSA. THE CONVERSION PROCEDURE WENT WELL. THE SURGEON COMMENTED THAT THE CASE WENT SMOOTHER OR EASIER THAN HE ANTICIPATED. THE PATIENT LEFT THE OPERATING ROOM (OR) STABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS. PHOTOS RECEIVED. THE DEVICE WILL BE RETURN. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16225004 ↗

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-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-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-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-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-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-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