Equinoxe 314-02-03 (UDI 10885862084484)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862084484), received between Nov 15, 2022 and Apr 17, 2025 — classified as 4 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, 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-1404-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Fracture; Mechanical Problem; Migration; Fracture; Mechanical Problem; Migration

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED 2 YEAR 2 MONTHS POST INITIAL OPERATION. THE CENTRAL PEG BROKE FROM IMPLANT AND IMPLANT WAS DISPLACED IN SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Insufficient Information; Loss of Range of Motion

  MAUDE report 21859165 ↗
• InjuryDec 18, 2024Naturally 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 LEFT ANATOMIC SHOULDER REPLACEMENT WAS REVISED. OVER TIME THE GLENOID COMPONENT FAILED AND BECAME LOOSE. THE SURGEON CARRIED OUT A STAGE ONE REVISION REMOVING THE EXISTING IMPLANTS AND INSERTING A CEMENT SPACER, WITH THE FUTURE PLAN TO CARRY OUT A STAGE TWO REVISION AND PUT A REVERSE SHOULDER BACK IN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 20968563 ↗
• InjuryAug 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 73 Y/O FEMALE PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 7 YEARS 2 MONTHS POST OP. THE PATIENT WAS REVISED DUE TO A FAILED GLENOID THAT CAME LOOSE. NO CEMENT BONDING BETWEEN THE BONE AND IMPLANT. REVISED FROM ANATOMIC TO REVERSE SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISCARDED.

  Patient problems: Aseptic loosening; Failure of Implant; Insufficient Information

  MAUDE report 19992248 ↗
• InjuryNov 15, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP THE INITIAL RIGHT TSA, THIS 48 Y/O MALE PATIENT WAS REVISED DUE TO A PAINFUL SHOULDER WITH LOOSE PEGGED ANATOMIC GLENOID. GLENOID WAS REVISED TO AN EQUINOXE REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETUNING, DISPOSED OF BY HOSPITAL.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15796831 ↗

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-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-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-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