Skip to content

Inverse/Reverse 01.04223.033Recalls & reported problems

Zimmer GmbH · Inverse/Reverse screw system, 4.5-33 · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024286016), received between Jun 6, 2024 and Jun 6, 2024 — classified as 2 injuries.

12 other recalls cover devices cleared under the same FDA submission (K052906); 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Osteolysis2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT WILL HAVE A REVISION FOR A PATIENT MATCHED IMPLANT DUE TO GLENOID BONE LOSS. A VAULT RECONSTRUCTION SYSTEM MAY BE REQUIRED, AND A REVISION HAS BEEN PLANNED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Osteolysis

    MAUDE report 19476335 ↗
  • InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT WILL HAVE A REVISION FOR A PATIENT MATCHED IMPLANT DUE TO GLENOID BONE LOSS. A VAULT RECONSTRUCTION SYSTEM MAY BE REQUIRED, AND A REVISION HAS BEEN PLANNED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Osteolysis

    MAUDE report 19476334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052906. One submission often covers many models, so check the product and lot details in each record.

  • Z-3144-2017 · May 22, 2017 · Terminated
    Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
  • Z-1079-2014 · Oct 17, 2013 · Terminated
    Trabecular Metal" Reverse Shoulder System
  • Z-2055-2013 · Aug 1, 2013 · Terminated
    00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate
  • Z-0571-2011 · Sep 10, 2010 · Terminated
    ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems
  • Z-0574-2011 · Sep 10, 2010 · Terminated
    Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3 The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, s
  • Z-0576-2011 · Sep 10, 2010 · Terminated
    Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option
  • Z-0575-2011 · Sep 10, 2010 · Terminated
    Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3. The Zimmer Trabecular Metal Shoulder System consists of convention
  • Z-0570-2011 · Sep 10, 2010 · Terminated
    ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems:
  • Z-0573-2011 · Sep 10, 2010 · Terminated
    TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-
  • Z-1416-06 · Jul 20, 2006 · Terminated
    Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.
  • Z-1418-06 · Jul 20, 2006 · Terminated
    Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
  • Z-1417-06 · Jul 20, 2006 · Terminated
    Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.

Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.