Equinoxe 314-13-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862172709), received between Sep 30, 2021 and Dec 29, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

7 other recalls cover devices cleared under the same FDA submission (K113309); 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-1412-2024 · Root cause: Nonconforming Material/Component · 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.

• InjuryDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED SEVERE BONE LOSS AND A FRACTURED POLYETHYLENE GLENOID IMPLANT. AS A RESULT, AN UNKNOWN AMOUNT OF TIME POST-SURGERY, THE PATIENT UNDERWENT A REVISION. ALL PIECES OF THE FRACTURED POLYETHYLENE WERE REMOVED FROM THE PATIENT. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 23913548 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 70 Y/O FEMALE PATIENT'S LEFT SHOULDER WAS REVISED. ROUTINE REVISION TO REVERSE SHOULDER. EXPLANTATION OF CAGE GLENOID COMPONENT DURING ROUTINE CONVERSION TO REVERSE SHOULDER ARTHROPLASTY. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING. UNABLE TO OBTAIN DEVICE IMAGES OR X-RAYS. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19566568 ↗
• InjuryNov 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 10 YEAR(S), 1 MONTH(S) AND 20 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF GLENOID COMPONENT. THE PATIENT WAS BEING MONITORED WITH PENDING CT, AND POSSIBLE REVISION. APPROXIMATELY 10 MONTHS FOLLOWING, THE PATIENT UNDERWENT A STANDARD TOTAL REVISION WITH THE REPORTED REMOVAL OF THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED, AND THE CASE REPORT FORM 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, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 18196999 ↗
• InjuryOct 2, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL RIGHT TSA, THE 62 Y/O FEMALE PATIENT HAD A REVISION DUE TO ROTATOR CUFF FAILURE ALONG WITH OSTEOLYSIS DUE TO POLY WEAR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Failure of Implant; Muscle/Tendon Damage; Osteolysis

  MAUDE report 17858234 ↗
• InjuryAug 22, 2023Defective Device; Loosening of Implant Not Related to Bone-Ingrowth; Defective Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 1 YEAR POSTOP THE INITIAL IMPLANT, THIS 66 YO MALE PATIENT WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. DEVICES WILL NOT BE RETURNED.

  Patient problems: Aseptic loosening; Discomfort; Failure of Implant

  MAUDE report 17596220 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 3 YEARS POSTOP THE INITIAL L TSA, THE PATIENT FELL ABOUT 6 MONTHS AGO, BUT NOTICED A SEVERE INCREASE IN PAIN IN SHOULDER 2-3MONTHS AGO. WAS DIAGNOSED WITH SEPTIC LOOSENING AND WAS SET UP WITH 2 STAGE REVISION WITH ANTIBIOTIC SPACER FIRST. OUTCOME REPORTED AS CONTINUING.

  Patient problems: Bacterial Infection

  MAUDE report 12553392 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113309. One submission often covers many models, so check the product and lot details in each record.

• Z-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• Z-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0415-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of
• Z-0414-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t