Equinoxe 320-36-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862086624), received between Oct 12, 2021 and Mar 27, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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

1 other recall cover devices cleared under the same FDA submission (K093275); 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-1416-2024 · Root cause: Nonconforming Material/Component · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1 YEAR AND 4 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH LOOSENING OF THE GLENOID SIDE COMPONENTS. NO INFECTION WAS PRESENT. THE PATIENT WAS REVISED AND THE SURGEON REMOVED THE GLENOID IMPLANTS, AND PACKED IT WITH BONE GRAFT. THE IMPLANT WAS CONVERTED TO A HEMI AND THE PATIENT WILL REVISIT IN 3 MONTHS TO DETERMINE WHEN A REVERSE CAN BE IMPLANTED. 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: Insufficient Information

  MAUDE report 21708534 ↗
• InjuryDec 6, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 3 MONTHS POST OP INITIAL RIGHT TSA, THIS 64 Y/O FEMALE PATIENT WAS REVISED. PATIENT DISLOCATED AND BECAME UNSTABLE. SURGEON REMOVED THE SMALL PROXIMAL BODY, +5 HUMERAL ADAPTER TRAY, +2.5MM 36MM LINER. TO CREATE GREATER STABILITY THE SURGEON ADDED A 25MM HRP MIDDLE SEGMENT, +0 PROXIMAL HUMERAL BODY SMALL, +0MM HUMERAL ADAPTER TRAY, 40MM +0 CONSTRAINED HUMERAL LINER. SURGEON WENT FROM A 36MM DJO GLENOSPHERE TO A 40MM GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - HOSPITAL POLICY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18278680 ↗
• InjuryNov 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 21 DAYS POST OP INITIAL RIGHT TSA, THIS 66 Y/O FEMALE PATIENT WAS REVISED DUE TO A TRAUMATIC DISLOCATION, SUPRASPINATUS RUPTURE RENDERING JOINT UNSTABLE. GLENOSPHERE AND HUMERAL LINER WERE EXCHANGED TO 38MM AND CONSTRAINED LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED.

  Patient problems: Joint Dislocation

  MAUDE report 18147586 ↗
• InjuryOct 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2020 AND PATIENT WAS IN SOME PAIN STILL AFTER HER REVISION. ON (B)(6) 2020 VISIT, X-RAYS INDICATED AN ANTERIOR SHOULDER DISLOCATION. THE PATIENT WAS REVISED ON (B)(6) 2020. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2020.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17986781 ↗
• InjuryFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THIS 65 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO DISLOCATION. THE INITIAL DISLOCATION WAS RELOCATED ON (B)(6) 2023, HOWEVER, OVERNIGHT THE PATIENT RE-DISLOCATED AGAIN. THE PLAN INITIALLY WAS TO UPSIZE THE HUMERAL LINER/TRAY, HOWEVER, ONCE OPEN, WHEN ATTEMPTING TO DISENGAGE THE TORQUE SCREW, THE HUMERAL STEM BECAME LOOSE. A NEW 9MM STEM WAS CEMENTED IN-SITU AND TRIALED OFF WHERE A +5MM TRAY AND +2.5 36MM CONSTRAINED HUMERAL LINER WAS IMPLANTED. 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: Joint Dislocation

  MAUDE report 16292908 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 9 MOS POSTOP A RTSA, THIS (B)(6) YEAR OLD FEMALE PATIENT FELT SUBLUXATION AND SELF REDUCED. THE CASE REPORT FORM FROM THE CLINICAL STUDY DATABASE INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME REPORTED AS RESOLVED ON (B)(6) 2021. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12618869 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093275. One submission often covers many models, so check the product and lot details in each record.

• Z-1417-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty