Equinoxe 320-38-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862086686), received between Aug 20, 2019 and Mar 24, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

2 FDA recall records name this device's identifier, 2 still open.

11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 6, 2024Class IIOpen, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1419-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0579-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Naturally Worn

  IT WAS REPORTED THAT A 77 YO FEMALE PATIENT, WHO HAD A LEFT RTSA, PRESENTED WITH COMPLAINTS OF PAIN AND WAS REVISED APPROXIMATELY 2 YEARS POST THE INITIAL PROCEDURE. A LOOSE BASEPLATE AND BACTEREMIA WERE INDICATED. 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 WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. AN IMAGE OF THE EXPLANTED DEVICES WAS PROVIDED. IMAGES OF THE EXPLANTED DEVICES SHOWED PROSTHESIS WEAR. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.

  Patient problems: Aseptic loosening; Bacteremia; Pain

  MAUDE report 24674704 ↗
• InjuryOct 27, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN APPROXIMATELY 5 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. RADIOGRAPHS TAKEN SHOWED THAT THE HUMERAL LINER AND HUMERAL TRAY HAD DISASSOCIATED. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER INITIAL IMPLANTATION. PROVIDED IMAGES OF THE EXPLANTED DEVICES SHOW SIGNS OF WEAR AND METAL-RELATED PATHOLOGY. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Metal Related Pathology; Pain

  MAUDE report 23391015 ↗
• InjuryJun 10, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED A 68 YO MALE PATIENT, WHO HAD A LEFT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE. IT APPEARED THE HUMERAL LINER WAS DISSOCIATED FROM THE HUMERAL PLATE. THE SURGEON BELIEVED THAT THE POLY HAD BEEN DISSOCIATED FOR QUITE SOME TIME PER THE X-RAYS. THE PATIENT HAD SIGNIFICANT METALLOSIS THROUGHOUT THE JOINT. BOTH THE HUMERAL STEM AND GLENOID BASEPLATE WERE LOOSE. THEY WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. PATIENT WILL BE REVISED AT A LATER DATE WITH A CUSTOM GLENOID. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 5 REPORTS FOR THIS EVENT THIS IS THE 2ND OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 22176550 ↗
• InjuryMar 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2024, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025. THE PATIENT PRESENTED WITH A DISLOCATION. THE SURGEON DECIDED TO CHANGE THE HUMERAL LINER. WHEN CHANGING THE LINER, IT WAS NOTICED THE STEM HAD COME LOSE. THE SURGEON CHANGED THE STEM, ADAPTER TRAY AND LINER. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISPOSED OF BY THE CUSTOMER. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 21526262 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1 WEEK AND 5 DAYS POST THE PREVIOUS LEFT SHOULDER REVISION SURGERY, THE SURGEON PERFORMED A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE DUE TO PERSISTENT INFECTION, AND DID A LIKE-FOR-LIKE EXCHANGE OF THE HUMERAL LINER. THE HUMERAL LINER WAS UNDAMAGED. 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: Unspecified Infection

  MAUDE report 21293089 ↗
• InjuryOct 16, 2024Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Lack of Effect; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Lack of Effect

  ADDITIONAL INFORMATION RECEIVED STATES THE PATIENT EXPERIENCED SYMPTOMS INCLUDING GRINDING NOISES, WORSENING PAIN, AND DECREASED RANGE OF MOTION, FOLLOWED BY SEVERE DISLOCATION AFTER A SLIGHT FALL IN 2024. THIS BECAME AN EMERGENCY SURGERY, SO CARE WAS TRANSFERRED TO ANOTHER SURGEON SO THAT IT COULD BE PERFORMED QUICKLY. THE SECOND EQUINOXE WAS REMOVED AT THAT TIME AND AN ANTIBIOTIC SPACER IMPLANTED TO RECTIFY THE SITUATION.

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 20466419 ↗
• InjuryOct 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 16 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, GRINDING, CRACKING NOISES AND SIGNIFICANTLY INCREASED PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20398106 ↗
• InjuryAug 22, 2023Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 6 MONTHS POSTOP THE INITIAL IMPLANT, THIS 60 YO MALE PATIENT WAS REVISED DUE TO DISASSOCIATION OF POLYETHYLENE. THE PATIENT REACHED OUT TO THE SIDE WHILE EXERCISING, FELT A "CLUNK". THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. DEVICES WILL NOT BE RETURNED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17599600 ↗
• InjuryAug 7, 2023Detachment of Device or Device Component; Noise, Audible; Separation Problem; Detachment of Device or Device Component; Noise, Audible; Separation Problem

  STUDY: EQUINOXE SHOULDER STUDY; SUBJECT: AY-150-L. IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 15 MONTHS POSTOP THE INITIAL IMPLANT, THIS 67 YO MALE PATIENT¿S SHOULDER WAS REVISED DUE TO DISASSOCIATION OF POLYETHYLENE. THE POLYETHYLENE DISSOCIATION OCCURRED WHEN REACHING TO PET DOG AND HEARING A "POP". THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 17471306 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WAS EXPERIENCING INSTABILITY OF THE LEFT SHOULDER WHICH WAS APPROXIMATELY 13 MONTHS PRIOR. A REVISION WAS SCHEDULED DUE TO INSTABILITY / DISLOCATION ISSUE WITH THE PATIENT. THE HUMERAL TRAY, TORQUE SCREW AND LINER WAS CHANGED IN THE PATIENT. IMPLANTS WERE REMOVED AND REPLACED. PATIENT LEFT OR STABLE. EXPLANTS WILL NOT BE RETURNED PER HOSPITAL POLICY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10730472 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 6.5 YRS POSTOP THE INITIAL IMPLANT, THE (B)(6) MALE PATIENT DISLOCATED THE RIGHT REVERSE SHOULDER WHICH LED TO THE REVISION SURGERY. THE SURGEON STATED THE HUMERAL LINER BECAME DISASSOCIATED FROM THE HUMERAL TRAY WHICH CAUSED THE DISLOCATION OF THE REVERSE SHOULDER AND THE REVISION SURGERY TO REDUCE THE REVERSE SHOULDER. PATIENT WAS STABLE WHEN LEAVING THE OPERATING ROOM. DEVICES TO BE RETURNED.

  Patient problems: Joint Dislocation

  MAUDE report 10023928 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A RIGHT SHOULDER ARTHROPLASTY ON (B)(6) 2018. THE PATIENT ALSO HAD A RIGHT PROXIMAL HUMERUS FRACTURE REPAIRED DURING THIS INITIAL IMPLANT PROCEDURE. ON (B)(6) 2019 THE PATIENT WAS SEEN WITH COMPLAINTS OF CLEAR YELLOW DRAINAGE X 2 DAYS. STATES WOUND IS RED, SWOLLEN, AND HOT. NO INCREASE IN PAIN. ON (B)(6) 2019, THE PATIENT HAD AN I & D FOR POSSIBLE INFECTION AND RECEIVED A DOWNSIZED HUMERAL LINER FROM 2.5 MM CONSTRAINED TO 0 MM CONSTRAINED. REASON FOR SIZE CHANGE WAS NOT REPORTED. INFORMATION RECEIVED INDICATES THE TREATMENT IS RESOLVED BY (B)(6) 2019.

  Patient problems: Discharge; Erythema; Swelling; Unspecified Infection

  MAUDE report 8912213 ↗

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-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-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-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-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-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.