Equinoxe 320-01-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862086402), received between Feb 28, 2020 and Oct 2, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (1 report).

13 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT REVERSE SHOULDER PUT IN 2020. REVISED AGAIN IN 2021 BY A LOCAL ORTHOPEDIC SURGEON. THEN PATIENT SAW A DIFFERENT SURGEON WHO REVISED THE PATIENT AND TOOK OUT HUMERAL COMPONENTS AND GLENOSPHERE AND REPLACED. THERE WAS A LOT OF MATELLOSIS AND THE TRAY WAS COMPLETELY SHEERED OFF THE STEM. THE STEM HAD OVERSTUFFED THE JOINT, A 15 PRESERVE STEM WAS USED. THE SURGEON COULD NOT FIND THE LINER POLY FROM THE ORIGINAL SURGERY. SURGEON CHECKED AROUND THE JOINT FOR IT AS WELL AS HIS PA AND ASSIST. NO ONE COULD FEEL FOR THE 46 +2.5MM LINER IN THE JOINT. PATIENT WAS REVISED TO A FX STEM AND A NEW GLENOSPHERE AND TRAY AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS, X-RAYS, AND EBI ATTACHED. PRODUCT NOT RETURNING: RISK MANAGER AT THIS FACILITY WILL NOT RELEASE IMPLANTS TO ME. ONLY RELEASE TO PATIENT. BUT I DO HAVE PICTURES. 300-30-15 EQUINOXE PRESERVE STEM 15MM (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K162726. PRODUCT CODE PHX, KWS, HSD, KWT. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K063569. PRODUCT CODE KWT. 320-46-03 - 145-DEG PE 46MM HUM LINER +2.5 (B)(6)

  Patient problems: Implant Pain; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 20351873 ↗
• InjuryMar 20, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL RIGHT TSA, THE 60 Y/O MALE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT WAS REVISED TO A 42MM, +4MM EXPANDED GLENOSPHERE AND A 42MM LINER. THE TORQUE SCREW KIT, ADAPTER TRAY AND LOCKING SCREW WERE ALSO REVISED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL DID NOT RETURN. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 18946343 ↗
• InjuryDec 14, 2021Break; Break

  AS REPORTED, APPROXIMATELY 5 MONTHS POSTOP THE INITIAL RIGHT TSA, THIS(B)(6) MALE PRESENTED WITH BROKEN SCREWS IN THE RIGHT SHOULDER AND WAS REVISED APPROXIMATELY 3 MONTHS LATER. AT THAT TIME, THE OUTCOME WAS REPORTED AS RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. DEVICES WERE NOT RETURNED PER STUDY PROTOCOL.

  Patient problems: Failure of Implant

  MAUDE report 13003559 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 WEEKS POSTOP A RIGHT TSA, A (B)(6) Y/O MALE PATIENT¿S SHOULDER WAS REVISED DUE TO DISLOCATION. THE SURGEON CHANGED OUT THE PROXIMAL BODY, HRP TAPER LOCKING SCREW, HUMERAL ADAPTER TRAY, REVERSE SHOULDER FIXED ANGLE TORQUE DEFINING SCREW AND THE REVERSE SHOULDER HUMERAL LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING, THE PATIENT REQUESTED THEM.

  Patient problems: Joint Dislocation

  MAUDE report 10363446 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YRS. POSTOP, A (B)(6) Y/O MALE WITH A ¿LARGER FRAME¿ CAME TO THE OR WITH HIS RIGHT SHOULDER DISLOCATED. AFTER TRAILING, THE SURGEON CHOSE TO IMPLANT THE SAME SIZED COMPONENTS THAT WERE REMOVED. DEVICES WILL NOT BE RETURNED.

  Patient problems: Joint Dislocation

  MAUDE report 10162574 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4MOS.POSTOP, A (B)(6) Y/O MALE WITH A ¿LARGER FRAME¿ CAME TO THE OR WITH HIS RIGHT SHOULDER DISLOCATED. AFTER TRAILING, THE SURGEON CHOSE TO IMPLANT THE SAME SIZED COMPONENTS THAT WERE REMOVED. DEVICES WILL NOT BE RETURNED.

  Patient problems: Joint Dislocation

  MAUDE report 10162520 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 MOS. POSTOP THE INITIAL IMPLANT, A (B)(6) Y/O MALE WITH A ¿LARGER FRAME¿ CAME TO THE OR WITH HIS RIGHT SHOULDER DISLOCATED. AFTER OPENING THE SHOULDER, IT WAS IDENTIFIED THAT THE POLY LINER WAS DISASSOCIATED FROM THE HUMERAL TRAY. AFTER TRAILING, THE SURGEON CHOSE TO IMPLANT THE SAME SIZED COMPONENTS THAT WERE REMOVED. DEVICES WILL NOT BE RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 10162479 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 YEARS POSTOP, THIS (B)(6) Y/O MALE¿S SHOULDER WAS DISLOCATED. AFTER OPENING THE SHOULDER, IT WAS IDENTIFIED THAT THE POLY LINER WAS DISASSOCIATED FROM THE HUMERAL TRAY. AFTER TRIALING, THE SURGEON CHOSE TO RE-IMPLANT THE SAME SIZED COMPONENTS THAT WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT ASKED FOR DEVICES, DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation

  MAUDE report 9956679 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS THE (B)(6) Y/O MALE PATIENT'S 3RD REVISION SURGERY ON RIGHT SHOULDER. APPROXIMATELY 26 MONTHS POSTOPERATIVE HIS LAST REVISION, THE PATIENT PRESENTED WITH PAINFUL SHOULDER AND WARM RED SKIN. SURGEON CULTURED AND EVIDENCE OF ELEVATED WHITE COUNT WAS FOUND. X-RAYS REVEALED OSTEOLYSIS OF PROXIMAL LATERAL HUMERUS. SURGEON CHOSE TO REMOVE OLD REVERSE IMPLANTS AND DO A SINGLE STAGE HEMI ARTHROPLASTY TO TREAT PATIENT. SURGERY WENT WELL AND SURGEON EXPECTS A GOOD OUTCOME FOR THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE ARE TO BE RETURNED.

  Patient problems: Osteolysis

  MAUDE report 9770502 ↗

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-2561-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
• 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-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-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-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-1422-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; 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-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-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 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.