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COPELAND SHOULDER SYSTEM 11-114648Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of COPELAND SHOULDER SYSTEM (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Aug 21, 2019Class IITerminated

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    Z-0527-2020 · Root cause: Environmental control · Recall details · FDA record ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page