Equinoxe 320-42-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862086716), received between Oct 18, 2019 and Mar 24, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 6, 2024Open, 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-1423-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Nov 21, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT SHOULDER REPLACEMENT. THE PATIENT LATER PRESENTED WITH LINER DISSOCIATION AND METALLOSIS. DURING THE REVISION PROCEDURE, THE SURGEON REMOVED THE HUMERAL STEM, GLENOSPHERE, HUMERAL TRAY, AND HUMERAL LINER. THE HUMERAL STEM WAS REPLACED WITH A STEM OF THE SAME SIZE. THE HUMERAL TRAY, HUMERAL LINER, AND GLENOSPHERE WERE REPLACED WITH COMPONENTS ONE SIZE LARGER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 24674977 ↗
• InjurySep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND ATRAUMATIC DISASSOCIATION OF THE HUMERAL LINER AND HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23009753 ↗
• InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 2 YEARS 3 MONTHS POST INITIAL OPERATION. THE REASON FOR THE REVISION WAS NOTCHING. THE SURGEON EXTRACTED AND REPLACED THE GLENOSPHERE AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Notching

  MAUDE report 22565903 ↗
• InjuryMar 11, 2025Naturally Worn; Naturally Worn

  AS REPORTED, FOLLOWING INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY (TSA) (IMPLANT DATE UNKNOWN), A REVISION WAS PERFORMED. THE SURGEON WAS UNSURE EXACTLY WHAT HAPPENED AS PATIENT HISTORY WAS VAGUE AND NON-SPECIFIC. THE SURGEON THEORIZED THAT THE CONSTRAINED LINER BECAME DISASSOCIATED FROM THE ADAPTER TRAY WHILE IMPLANTED IN THE PATIENT LEADING TO SUBLUXATION OF THE JOINT; HOWEVER, THIS WAS NOT CONFIRMED. THE LINER WAS REPORTEDLY IN SITU WHEN THE PATIENT WAS OPENED UP AND IMPLANTS WERE REPLACED. THE LINER, ADAPTER TRAY, AND TORQUE SCREW WERE REPLACED. THE EVENT WAS UNRELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Subluxation

  MAUDE report 21573194 ↗
• InjuryNov 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  APPROXIMATELY 4 MONTH(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ANOTHER DISLOCATION. SUBJECT REPORTS A POP DURING STRETCHING EXERCISES IN POSTOPERATIVE PHYSICAL THERAPY APPOINTMENT. AFTER VISITING A WALK-IN ORTHOPAEDIC CLINIC, X-RAYS REVEALED A DISLOCATED PROTHESES. THE SUBJECT WAS PREVIOUSLY GIVEN MEDICATION AND THEN UNDERWENT A STANDARD REVERSE WITH HUMERAL RECONSTRUCTION REVISION WITH THE REMOVAL OF THE HUMERAL LINER. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20663476 ↗
• InjuryMay 17, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 7 YEAR AND 7 MONTHS POST THE INITIAL LEFT TSA, THE 68 YEAR OLD MALE PATIENT WAS REACHING OUT AND HEARD A POP IN THEIR SHOULDER. THE PATIENT WAS REVISED ON (B)(6) 2024 AND CONVERTED TO A 15MM ADAPTOR TRAY AND THE NEW REINFORCED 145 DEGREE POLY 2.5MM CONSTRAINED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 19341586 ↗
• InjuryApr 21, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIX MONTHS POST INITIAL RIGHT TSA, THE 66 Y/O MALE PATIENT WAS REVISED DUE TO PAIN IN HIS SHOULDER. PRIOR TO SURGERY, PATIENT HAD A +5 TRAY, +0MM CONSTRAINED LINER AND 42MM GLENOSPHERE. PATIENT GLENOSPHERE WAS EXCHANGED FOR A 38MM LATERALIZED GLENOSPHERE AND A +5MM TRAY WITH A +0MM CONSTRAINED LINER. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS HOSPITAL DOESN'T RELEASE IMPLANTS.

  Patient problems: Pain

  MAUDE report 16786602 ↗
• InjuryMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 62 Y/O MALE PATIENT UNDERWENT RTSA SURGERY. AT A LATER DATE, THE PATIENT UNDERWENT A BACK SURGERY PROCEDURE. FOLLOWING THIS PROCEDURE, THE PATIENT REPORTED SHOULDER PAIN. THE PATIENT WAS OBSERVED TO BE DISLOCATED. IN REVISION SURGERY, THE HUMERAL LINER COMPONENT WAS OBSERVED TO BE DISLODGED FROM THE TRAY. THE LINER WAS REPLACED. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION, IMAGES AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO EXPLANTS ARE RETAINED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 16545563 ↗
• InjurySep 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. THE PATIENT WAS DEEMED STABLE AFTER THE REVISION. THERE WAS NO REPORTED BREAKAGE OF DEVICE(S) OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES ARE NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15481974 ↗
• InjuryJul 23, 2021Unintended Movement; Unintended Movement

  THE PATIENT PRESENTED WITH SHOULDER PAIN AND DECREASED MOTION AFTER HAVING AN EQUINOXE REVERSE SHOULDER REPLACEMENT 11 YEARS AGO. ORIGINAL SURGERY INFORMATION IS UNKNOWN. THE PATIENT WAS SCHEDULED FOR A LEFT REVISION REVERSE TSA. ONCE THE SHOULDER IMPLANTS WERE EXPOSED THE POLY WAS EXAMINED AND FOUND TO HAVE MOVEMENT WITHIN THE HUMERAL TRAY. THE REVERSE LINER WAS LOCKED DOWN ALL THE WAY ONTO THE TRAY, HOWEVER, IT WAS SPINNING OR MOVING FROM LEFT TO RIGHT WITHIN AND WHILE LOCKED INTO THE TRAY. THERE WAS OBVIOUS METALLOSIS WITHIN THE JOINT. THE POLY LINER WAS REMOVED FROM THE HUMERAL TRAY. THE TORQUE SCREW AND HUMERAL WERE REMOVED FROM THE STEM. THE STEM VERSION AND STABILITY WERE CHECKED AND FOUND TO BE STABLE. ATTENTION WAS THEN DRAWN TO THE GLENOID IMPLANTS. THE GLENOSPHERE LOCKING SCREW AND GLENOSPHERE WERE REMOVED. THE BASEPLATE WAS CLEANED AND CHECKED FOR LOOSENING. IT WAS FOUND TO BE STABLE. AFTER DEBRIDEMENT AND RELEASE OF THE SHOULDER ANATOMY, THE SURGEON DECIDED TO IMPLANT THE 42 +4MM LATERALIZED GLENOSPHERE. IT WAS SECURED WITH A NEW GLENOSPHERE LOCKING SCREW. ATTENTION WAS DRAWN BACK TO THE HUMERUS WHERE TRIALING TOOK PLACE TO DECIDE ON A +5MM HUMERAL TRAY AND A +0MM 42MM

  Patient problems: Failure of Implant

  MAUDE report 12217081 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS MALE PATIENT HAD ISSUES WITH AN R SHOULDER INFECTION OVER THE LAST 2 WEEKS SINCE THE INITIAL TSA IMPLANT. THE PATIENT WAS REVISED, AND AN ANTIBIOTIC SPACER WAS PLACED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT, DEVICES WILL NOT RETURN, FACILITY DISPOSED OF THEM.

  Patient problems: Bacterial Infection

  MAUDE report 11751704 ↗
• InjuryFeb 24, 2021Device Dislodged or Dislocated; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2 MONTHS POSTOP THE INITIAL IMPLANT, THIS PATIENT WAS TWISTING AND FELT A POP IN THE L SHOULDER WHICH DISLOCATED. THE LTSA WAS REVISED DURING A SAME DAY SURGERY VISIT. THE ISSUE WAS NOTED AS RESOLVED. THE DEVICE WILL NOT RETURN DUE TO CLINICAL STUDY POLICY. THIS INFORMATION WAS REPORTED BY A CLINICAL STUDY DATABASE. ALL AVAILABLE INFORMATION IS REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 11371611 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD FAILURE OF A REVERSE TOTAL SHOULDER DUE TO DISLOCATION. . REVISION REPLACED THE HUMERAL LINER AND GLENOSPHERE, ALONG WITH THE ASSOCIATED LOCKING SCREWS. PATIENT WAS STABLE UPON LEAVING THE OR AND THERE WAS NOT A DELAY TO SURGERY. DEVICES NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Joint Dislocation

  MAUDE report 9769066 ↗
• InjuryOct 18, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON EXPLANTED A 42+0 CONSTRAINED HUMERAL LINER THAT DISASSOCIATED FROM THE HUMERAL ADAPTER TRAY DUE TO A DISLOCATION OF A REVERSE SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 9207743 ↗

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-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-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-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-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.