Equinoxe 314-02-14 (UDI 10885862084521)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862084521), received between Oct 3, 2019 and Apr 7, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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

9 other recalls cover devices cleared under the same FDA submission (K042021); 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-1405-2024 · 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.

• InjuryApr 7, 2026Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT ANATOMIC IMPLANT CONSTRUCT AND PRESENTED TO THE SURGEON¿S OFFICE WITH SIGNS AND SYMPTOMS OF AN INFECTION. THE PATIENT WAS SCHEDULED FOR AN EXCISION/ REMOVAL OF THE TOTAL SHOULDER ARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE PATIENT UNDERWENT THE PROCEDURE AND THE IMPLANTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS PLACED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGING WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24811840 ↗
• InjuryJan 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 6 MONTH(S) AND 26 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED SEPTIC LOOSENING WITH SEVERE PAIN. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION FOR THE LOOSENING WITH THE REPORTED REMOVAL OF THE GLENOID COMPONENT. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED 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: Medical device site infection; Pain

  MAUDE report 21087933 ↗
• InjuryJul 5, 2024Naturally Worn; Naturally Worn

  A PATIENT REPORTED THE NEED FOR A REVISION APPROXIMATELY 15 YEARS AFTER INITIAL TSA PERFORMED IN 2009 THROUGH THE ETHICS HOTLINE. SINCE THE INITIAL REPLACEMENT, THE PATIENT HAS EXPERIENCED PAIN AND INFECTION. A REVISION WAS SCHEDULED FOR SEPTEMBER AFTER A SURGEON CONFIRMED THERE WAS LOOSE PLASTIC IN THE SHOULDER.

  Patient problems: Medical device site infection; Pain; Unspecified Infection

  MAUDE report 19680105 ↗
• InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  APPROXIMATELY 11 YEARS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT, SURGEON DECIDED PATIENT INDICATIONS NECESSITATED REVISION SHOULDER ARTHROPLASTY. SURGEON EXPLANTED IN-SITU IMPLANTS: ALL POLY GLENOID, HUMERAL HEAD, REPLICATOR PLATE AND TORQUE DEFINING SCREW. SURGEON IMPLANTED NEW REPLICATOR PLATE, TORQUE DEFINING SCREW AND HUMERAL HEAD. EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: HOSPITAL RETAINS THE PRODUCTS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19621083 ↗
• InjuryApr 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 68-YEAR-OLD NON-HISPANIC WHITE MALE HAD A LEFT TSA ON (B)(6) 2009. THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING ON AN UNKNOWN DATE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY TO THE PROCEDURE. ANOTHER EVENT INVOLVING THIS PATIENT IS RELATED TO AND RECORDED ON (B)(6).THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19214767 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 13 YEARS POST OP THE INITIAL TSA, THIS PATIENT WAS REVISED DUE TO INFECTION. THE STEM WAS WELL FIXED BUT WAS NOT DIFFICULT TO REMOVE WITH SLAPHAMMER. GLENOID WAS LOOSE AND EASILY REMOVED WITH CEMENT REMAINING ON THE BACK OF THE COMPONENT PEGS. PATIENT WAS TREATED WITH ANABIOTIC SHOULDER SPACER AN ANTIBIOTIC BEADS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO PATIENT INFORMATION OR MEDICAL HISTORY IS AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 13333672 ↗
• InjuryNov 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O MALE PATIENT HAD A RIGHT PRIMARY TOTAL DONE ON (B)(6) 2012. GLENOID BECAME LOOSE AND A LARGE CENTRAL DEFECT FORMED. GLENOID WAS REMOVED AND THE DEFECT WAS FILLED WITH BONE AUTOGRAFT FROM CLAVICLE. GLENOID WAS REAMED AND A HEMI WAS PERFORMED. PATIENT IS EXPECTED TO DO WELL AND LEFT OPERATING ROOM STABLE. 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 12821296 ↗
• InjuryOct 3, 2019Therapeutic or Diagnostic Output Failure

  AS REPORTED, THE LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED ON THIS MALE PATIENT ON (B)(6) 2018. PATIENT HAD A FAILED SUBSCAPULARIS, AND SURGEON CONVERTED TO A REVERSE FOR BETTER FUNCTION AND A NEW STEM WAS CEMENTED IN PLACE. PATIENT LEFT OR STABLE AND SURGEON BELIEVED THERE WOULD BE A SUCCESSFUL OUTCOME. EXPLANTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: No Information

  MAUDE report 9152293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.

• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty