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NA 09.405.963SRecalls & reported problems

Synthes GmbH · RADIAL HEAD W/ Ø19MM HD, Ø6.5MM STM,9(+3)MM HD HT,STER · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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, 1 still open.

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.

Recalls naming this device

  1. Apr 7, 2022Open, Classified

    DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

    Z-1072-2022 · Root cause: Labeling Change Control · FDA record ↗

Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices

All PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices →

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