Anatomical Shoulder™ Reverse 01.04223.100Recalls & reported problems
Zimmer GmbH · AS Inverse Humeral Cup, standard · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024286054), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 injury.
3 other recalls cover devices cleared under the same FDA submission (K053274); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT THAT HAD A REVISION DUE TO INFECTION APPROXIMATELY FIVE (5) MONTHS AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 18231961 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053274. One submission often covers many models, so check the product and lot details in each record.
- Z-0230-2013 · Sep 4, 2012 · TerminatedAnatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
- Z-0231-2013 · Sep 4, 2012 · TerminatedAnatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
- Z-0229-2013 · Sep 4, 2012 · TerminatedAnatomical Shoulder" Inverse Humeral Cup
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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