Equinoxe 314-02-02 (UDI 10885862084477)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862084477), received between Jun 10, 2021 and Sep 2, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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-1404-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S ATSA (ANATOMIC TOTAL SHOULDER ARTHROPLASTY) WAS REVISED TO A RTSA (REVERSE TOTAL SHOULDER ARTHROPLASTY) APPROXIMATELY 11 YEARS 6 MONTHS POST INITIAL OPERATION. THE PHOTOS PROVIDED SHOW SIGNS OF WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22945884 ↗
• InjuryMay 21, 2025Material Deformation; Material Deformation

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY AT A PRIVATE HOSPITAL IN FRANCE ON AN UNKNOWN DATE. THE PATIENT WAS REVISED DUE TO ROTATOR CUFF FAILURE AND THE IMPLANTS WERE REMOVED TO ELIMINATE THE CHANCE OF INFECTION. A SPACER WAS IMPLANTED TO REDUCE THE RISK OF INFECTION AND ALLOW FOR PLANNING OF THE GLENOID FOR SECOND STAGE REVISION. 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: Muscle/Tendon Damage

  MAUDE report 22061945 ↗
• InjuryMar 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED EXCESSIVE WEAR OF IMPLANT COMPONENTS SECONDARY TO DAMAGE OF ARTICULAR SURFACES, AS WELL AS PAIN AND FUNCTIONAL IMPOTENCE. AS A RESULT, APPROXIMATELY 11 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21647530 ↗
• InjuryMar 17, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 13 YEARS 6 MONTHS POST INITIAL OPERATION. THE PATIENT PRESENTED TO THE SURGEONS OFFICE WITH COMPLAINTS OF PAIN AND DECREASED MOTION IN THEIR SHOULDER. IT IS SHOWN ON IMAGING THAT THE GLENOID IMPLANT IS WORN AND POTENTIALLY LOOSE. THE PRIMARY SHOULDER HAS MIGRATED SUPERIORLY INDICATING ROTATOR CUFF FAILURE. THE HUMERAL HEAD, REPLICATOR PLATE AND PRIMARY TORQUE SCREW WERE REMOVED. THE ALL POLY GLENOID WAS LOOSE AND REMOVED FROM THE JOINT. THERE WAS BONE AND TISSUE GROWTH AROUND THE GLENOID THAT WAS DEBRIDED. THERE WAS OSTEOLYSIS AROUND THE HUMERAL STEM AND BEHIND THE GLENOID. THE HUMERAL STEM WAS CHECK FOR VERSION AND STABILITY. THE HUMERAL STEM WAS STABLE AND PACKED WITH BONE GRAFT. THE GLENOID WAS FRACTURED ACROSS THE CENTRAL ASPECT. THE SURGEON BELIEVED A CAGE OR PEG IMPLANT WOULD CAUSE A LARGER FRACTURE. BONE GRAFT WAS APPLIED TO THE GLENOID. THE SURGEON USED A DJO REVERSE BASEPLATE WITH A CENTRAL SCREW AND LOCKING PERIPHERAL SCREWS ALONG WITH A 36MM GLENOSPHERE. THE TRAY AND LINER WERE TRAILED UP TO A +2.5MM CONSTRAINED FOR 36MM AND WERE STABLE THROUGH ROM. THE SURGEON IMPLANTED THAT CONSTRUCT WITH THE REAL I

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 21627553 ↗
• InjuryNov 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S), 8 MONTH(S) AND 30 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS FURTHER REPORTED PAIN WITH AROM. THE PATIENT UNDERWENT A HEMIARTHROPLASTY SPACER 2-STAGE REVISION WITH THE REPORTED REMOVAL OF THE GLENOID COMPONENT. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL REPORT 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 AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20774852 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 11 YEARS 9 MONTHS POST OP. THE REVISION WAS A PLANNED REVISION OF AN ANATOMIC SHOULDER REPLACEMENT TO A REVERSE SHOULDER REPLACEMENT. THIS WAS CONDUCTED DUE TO PATIENT CUFF WEAR AFTER 12 YEARS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 20552680 ↗
• InjurySep 11, 2024Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 8 YEAR(S), 11 MONTH(S) AND 16 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT CONTINUED TO EXPERIENCE PAIN AND DECREASED ROM. CT SCAN DEMONSTRATED LOOSENING BEHIND THE GLENOID COMPONENT WITH SOME CYSTIC CHANGES BEHIND THE GLENOID. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Cyst(s); Loss of Range of Motion; Pain

  MAUDE report 20191795 ↗
• InjuryNov 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS (B)(6) FEMALE PATIENT PRESENTED WITH DISSOCIATION OF POLYETHYLENE LINER WITHOUT TRAUMATIC INCIDENT. SHOULDER IS ALSO DISLOCATED ANTERIORLY. AND WAS CONVERTED TO RTSA OF THE RIGHT SHOULDER. OUTCOME REPORTED AS RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 12900718 ↗
• InjurySep 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 41 MONTHS POSTOP THE INITIAL RIGHT TSA, THE (B)(6) Y/O FEMALE PATIENT WAS PULLING A RUG AND IN A DIFFERENT INSTANCE PICKING UP A CHRISTMAS TREE WHEN SHE FELT A SHARP PAIN. SINCE THEN HAS HAD INCONSISTENT BUT FREQUENT SHARP PAIN WITH ADLS. SURGEON DIAGNOSED AS ASEPTIC GLENOID LOOSENING. PATIENT IS CONSIDERING REVISION SURGERY. WILL BE SEEN BACK AGAIN TO FURTHER DISCUSS. OUTCOME: CONTINUING.

  Patient problems: Failure of Implant

  MAUDE report 12431964 ↗
• InjuryJun 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 YRS POSTOP THE INITIAL R TSA FOR THIS FEMALE PATIENT, THE RIGHT SHOULDER ALL-POLY GLENOID HAD LOOSENED. THE REASON FOR THE LOOSENING IS UNKNOWN, SURGEON DID NOT SUSPECT INFECTION. SURGEON REMOVED ALL COMPONENTS IN A SINGLE STAGE REVISION, CONVERTING TO A REVERSE USING AN EXTENDED CAGE AND BONE GRAFT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES TO BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11973898 ↗

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-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• 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-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