NA 09.405.263SRecalls & reported problems
Synthes GmbH · RADIAL HEAD W/ Ø22MM HD, Ø6.5MM STM,10(+3)MM HD HT,STER · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982300652), received between Feb 2, 2023 and Feb 2, 2023 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO OTHER MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Unspecified Tissue Injury
MAUDE report 16287124 ↗
Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices
- EVOLVE 496S275Wright Medical Technology, Inc. · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall6 reports
- NA 03.405.000SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 09.405.966SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 09.405.250SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.583SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.570SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.963SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall0 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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