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Knee Instruments 11.01041Recalls & reported problems

Medacta International SA · Sphere CR Insert Instrument Set I1L-T1 · Class 1

All models of Knee Instruments (33)

Data updated Oct 16, 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 16, 2026.

Recalls naming this device

  1. Apr 13, 2022Terminated

    A Size 2 trial baseplate was assembled with Size 1 instrument sets.

    Z-1247-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Other Orthopedic Manual Surgical Instrument devices

All Orthopedic Manual Surgical Instrument devices →

Sources and updates

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