Equinoxe 320-38-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862086679), received between Jul 10, 2020 and Feb 9, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

12 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 16, 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-1419-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• InjuryFeb 9, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY TWO YEARS AFTER THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT REPORTEDLY FELL, RESULTING IN A NONDISPLACED PERIPROSTHETIC FRACTURE. THE FRACTURE WAS TREATED NONOPERATIVELY. THERE HAVE BEEN NO ADDITIONAL REPORTED EVENTS SINCE THEN. THE PATIENT RECENTLY REPORTED INSTABILITY. THE PATIENT WAS REVISED AND THE HUMERAL LINER WAS FOUND TO BE DISSOCIATED FROM THE HUMERAL TRAY. IT IS UNCLEAR WHEN THIS DISSOCIATION TOOK PLACE.

  Patient problems: Joint Laxity

  MAUDE report 21341153 ↗
• InjuryNov 5, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY ONE MONTHS POST OPERATION. HRP WAS DISLOCATING DUE TO LACK OF SOFT TISSUE TENSION. PATIENT REVISED TO EXACTECH DEVICES: LINER AND GLENOSPHERE WERE UPSIZED TO 42MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 20614884 ↗
• InjuryOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 3 YEARS AND 9 MONTHS POST THE INITIAL LEFT TSA, THE PATIENT PRESENTED WITH A DISASSOCIATED LINER. THE GLENOSPHERE, ADAPTER TRAY AND LINER WERE EXCHANGED. 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: Insufficient Information

  MAUDE report 20359078 ↗
• InjuryAug 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 60 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON(B)(6) 2024 , UNDERWENT A REVISION PROCEDURE 5 DAYS POST DUE TO A DISLOCATION. THE HUMERAL STEM, ADAPTER TRAY AND LINER WERE EXCHANGED. A CONSTRAINED LINER WAS IMPLANTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS AS THEY WERE DISCARDED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 19996461 ↗
• InjuryMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL LEFT TSA, THE 67 Y/O MALE PATIENT HAD A REVISION DUE TO POLY DISASSOCIATED. THE PATIENT WAS REVISED TO UPSIZED HUMERAL TRAY AND LINER. THE PATIENT IS STABLE. THERE WAS NO BREAKAGE THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18946700 ↗
• InjuryMar 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR MONTHS POST RIGHT TSA, THE 58 Y/O MALE FEMALE PATIENT HAD A FIRST STAGE REMOVAL OF AN EXACTECH REVERSE SHOULDER DUE TO INFECTION. AN ANTIBIOTIC SPACER WAS IMPLANTED AFTER ALL IMPLANTS WERE REMOVED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 18919053 ↗
• InjuryNov 27, 2023Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT A 68 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON OCTOBER 31, 2023. THE PATIENT¿S TRAY AND POLY WERE REVISED DUE TO INSTABILITY. THE XRAY SHOWED THE TRAY RIGHT UP AGAINST THE GLENOSPHERE, (METAL ON METAL), SO THE POLY HAD BECOME DISLODGED. THE +0 TRAY AND 38MM +0 CONSTRAINED LINER WERE SWAPPED FOR A NEW +0 TRAY WITH A 38MM +2.5 CONSTRAINED LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT ABLE TO BE RETURNED AS THE HOSPITAL DOES NOT ALLOW IT. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Metal Related Pathology

  MAUDE report 18210166 ↗
• InjuryApr 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO DISSOCIATION OF THE LINER FROM THE TRAY WHILE LIFTING DOG CAGES. PATIENT WAS ON VACATION IN (B)(6) TWO WEEKS AGO. WHILE LIFTING DOG CAGES HE FELT A POP IN THE SHOULDER FOLLOWED BY PAIN AN INABILITY TO ROTATE THE ARM EASILY. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES HAVE BEEN RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 14012836 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 8 MONTHS AFTER THE INITIAL IMPLANT, THIS MALE PATIENT EXPERIENCED INSTABILITY OF RIGHT SHOULDER. DURING A REVISION, THE SURGEON UPSIZED THE COMPONENTS. INSTABILITY OCCURRED OVER TIME. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 10257072 ↗

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-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-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-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-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.