Equinoxe 314-13-15 (UDI 10885862172723)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862172723), received between Jan 29, 2021 and Jan 7, 2025 — classified as 8 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-1413-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, INFLAMMATION, LIMITED RANGE OF MOTION AND COMPONENT LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Inflammation; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21090869 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20038519 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 9 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TSA, THE CAGE GLENOID WAS EXPLANTED DURING ROUTINE CONVERSION FROM AN ANATOMIC TO A REVERSE TOTAL SHOULDER. THE HUMERAL HEAD, REPLICATOR PLATE AND DISENGAGED TORQUE DEFINING SCREW WERE ALSO EXPLANTED AT THE SAME TIME. THE SCREW WAS COMPLETELY DISENGAGED FROM THE STEM, BUT THE COLD WELD BETWEEN THE REPLICATOR PLATE AND THE STEM WAS INTACT AND WAS BROKEN AT THE TIME OF EXPLANTATION. 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: Failure of Implant

  MAUDE report 19506838 ↗
• InjuryOct 23, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2017. THE PATIENT PRESENTED ON (B)(6) 2023 AND HAD ANTERIOR SHOULDER INSTABILITY. THE PATIENT WAS REVISED ON (B)(6) 2024. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE. OUTCOME: CONTINUING.

  Patient problems: Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 17984138 ↗
• InjuryAug 3, 2023No Apparent Adverse Event; Lack of Effect; No Apparent Adverse Event; Lack of Effect

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 70 YO PATIENT EXPERIENCED A STIFF SHOULDER, WITH REPORTS OF INCREASED PAIN WITH LIMITED ROM IN RT. SHOULDER. ONSET 5-6 MONTHS AGO ((B)(6) 2021). NO TRAUMATIC INJURY NOTED. THE PATIENT WILL FOLLOW UP IF NEEDED AFTER 6 WEEKS OF PHYSICAL THERAPY. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain

  MAUDE report 17451923 ↗
• InjuryApr 7, 2023Fracture; Fracture

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL TSA, THE MALE PATIENT HAD A REVISION OF CAGE GLENOID DUE TO PROSTHESIS FRACTURE. REVISED ON (B)(6) 2023 TO A REVERSE. ALL COMPONENTS REMOVED. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 16704092 ↗
• InjuryMar 6, 2023Fracture; Fracture

  AS REPORTED, MALE PATIENT HAD A CAGE GLENOID REVISION DUE TO POLY FRACTURE AND METALOSIS. THERE WERE FRAGMENTS, PARTS OR PIECES REMOVED FROM PATIENT DUE TO THE FRACTURED POLY. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS & X-RAYS RECEIVED, THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 16488096 ↗
• InjuryJan 29, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O MALE PRESENTED WITH RIGHT ASEPTIC GLENOID LOOSENING AND WAS REVISED. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED TO THE PROCEDURE. THE PATIENT WAS DISCHARGED IN 2 DAYS. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 11250293 ↗

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-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-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• 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