Equinoxe 320-20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862086556), received between Jun 2, 2023 and May 29, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Structural Problem; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 2 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DECREASED RANGE OF MOVEMENT. UPON EXAMINATION AND IMAGING REVIEW FROM PREVIOUS POST-OP, AND THE RECENT OFFICE VISIT X-RAYS, AND ACCORDING TO THE IMPLANT RECORD WITH A STANDARD BASEPLATE BEING USED, IT APPEARED THE GLENOSPHERE WAS NOT COMPLETELY ENGAGED AND DOWN ON THE BASEPLATE. HOWEVER, THE LOCKING SCREW WAS STILL ENGAGED AND GAVE THE SURGEON A FALSE FEEDBACK IN THE INITIAL SURGERY THAT THE IMPLANT WAS DOWN AND SECURE. THE IMPLANT WAS NOT DOWN COMPLETELY AND SECURE, AND OVER TIME THE GLENOSPHERE LOCKING SCREW DISENGAGED FROM THE MECHANISM AND THE GLENOSPHERE IMPLANT LEVERAGED OFF OF THE GLENOID BASEPLATE. THERE WAS/IS EVIDENCE OF HUMERAL POLY LINER WEAR AND BONE RESORPTION/OSTEOLYSIS AROUND THE IMPLANTS. THE PATIENT WAS REVISED, AND DURING THE REVISION, THE PATIENT'S SHOULDER JOINT AND SURROUNDING TISSUE SHOWED METALLOSIS. THE JOINT AND TISSUES WERE DEBRIDED. THE BROKEN AND DISENGAGED IMPLANTS WERE REMOVED. THE HUMERAL STEM WAS TESTED FOR STABILITY. THE GLENOID BASEPLATE SHOWED TO BE STABLE, SO THE SUR

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

  MAUDE report 25336748 ↗
• InjuryJan 12, 2026Fracture

  IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. THE BASEPLATE WAS OBSERVED TO BE DISLODGED FROM THE GLENOID ON CT. ONE OF THE SCREWS WAS OBSERVED TO BE BROKEN. THE HUMERAL LINER & TRAY WERE REMOVED. THE STEM WAS STILL WELL-FIXED DESPITE PROXIMAL HUMERAL BONE LOSS. THE GLENOSPHERE WAS REMOVED. THE BASEPLATE WITH ALL FOUR SCREWS WAS PULLED OUT AS ONE PIECE. ONE OF THE SCREWS WAS BROKEN. THE SURGEON FILLED THE BONE VOID WITH CAP & USED COMPETITOR¿S COMPONENTS FOR THE GLENOID BASEPLATE & GLENOSPHERE. THE SURGEON THEN IMPLANTED A NEW HUMERAL TRAY & LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY IMAGE WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 24048723 ↗
• InjurySep 4, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 4 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TSA, THE PATIENT WAS REVISED DUE TO THE POSTERIOR/INFERIOR LOCKING CAP BACKING OUT AND COMING LOOSE. THE METAL BACK FEEL OUT AND CAUSED INFECTION. IT WAS INFECTED AND THE ENTIRE GLENOID CONSTRUCT WAS LOOSE AND THE SCREW BROKE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20141594 ↗
• MalfunctionJun 3, 2024Break; Break

  AS REPORTED, THE SURGEON WAS SCREWING THE BLUE COMPRESSION SCREW INTO THE GLENOID PLATE AND A SMALL SPIRAL OF METAL CAME OFF THE SCREW. THE SURGEON DID NOT WANT A NEW COMPRESSION SCREW, HE WAS HAPPY WITH THE SCREW AND CONTINUED ON WITH THE SURGERY. ALL FRAGMENTS/PARTS/PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION.

  Patient problems: Failure of Implant

  MAUDE report 19448558 ↗
• InjuryJun 2, 2023Break; Fracture; Break; Fracture

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL LEFT TSA, THIS 72 Y/O MALE PATIENT WAS REVISED. THE PATIENT ORIGINALLY HAD AN EXACTECH REVERSE SHOULDER IMPLANTED. AT SOME POINT THE GLENOSPHERE BECAME DISASSOCIATED FROM THE BASEPLATE. ANOTHER SURGEON IN (B)(6) IL REVISED THE SHOULDER IMPLANTING THE ABOVE LISTED IMPLANTS ON (B)(6) 2021 AT (B)(6) (CAPTURED IN 1038671-2023-01183). THE BASEPLATE AND STEM WERE NOT REMOVED BUT SCREWS WERE ADDED AND A NEW GLENOSPHERE AND LINER WERE IMPLANTED. AFTER THAT CASE THE GLENOID BASEPLATE BECAME PULLED OUT FROM THE GLENOID AND WAS FREE FLOATING IN THE SHOULDER BASED ON XRAY. SURGEON SCHEDULED A CASE TO REVISE THE SHOULDER TO A HEMI ON (B)(6) 2023. DURING THE CASE THE SURGEON EXPOSED THE HUMERUS AND REMOVED BOTH THE LINER AND THE +0 TRAY HE THEN MOVED ON TO THE GLENOID WHERE HE WAS ABLE TO PULL OUT THE GLENOSPHERE INCLUDING THE BASEPLATE AND ALL SCREWS. ONE SCREW HAD BEEN BROKEN OFF IN THE GLENOID FROM A PREVIOUS SURGERY OR FROM WHEN THE GLENOID COMPONENT BECAME LOOSE. THE BROKEN SCREW WAS NOT RETRIEVED AND WAS LEFT IN THE GLENOID. SURGEON THEN IMPLANTED A 1.5 REPLICATOR PLATE (300-21-00 A197490) AND 47 X 18 HEAD (310-01-47 A373263). SURGEON DID

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17049326 ↗

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-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-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-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-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-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-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-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 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.