NA 09.405.570SRecalls & reported problems
Synthes GmbH · RADIAL HEAD W/ Ø25MM HD, Ø7.5MM STM,11(+0)MM HD HT,STER · Class 2 · Implant
Data updated Oct 18, 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 10886982300768), received between Apr 19, 2024 and Apr 19, 2024 — 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 18, 2026.
Reports received per month
Recalls naming this device
- Apr 7, 2022Class IIOpen, 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
- Joint Contracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS RELATED TO DATA USE AGREEMENT (DUA) WHICH INCLUDES SAFETY RELATED DATA ON SYNTHES RADIAL HEAD REPLACEMENT (RHR) SYSTEM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY REPLACEMENT AFTER FRACTURE OF THE RADIAL HEAD. POSTOPERATIVE COMPLICATION REPORTED AS PERSISTENT ELBOW CONTRACTURE WITH HETEROTROPHIC OSSIFICATION WHICH WAS TO BE MITIGATED VIA CAPSULAR RELEASE AND HARDWARE REMOVAL OF ULNA PLATE (RHR IMPLANT WAS NOT REMOVED). THIS REPORT IS FOR ONE (1) RADIAL HEAD W/ Ø25MM HD, Ø7.5MM STM,11(+0)MM HD HT,STER THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Joint Contracture
MAUDE report 19145134 ↗
Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices
- EVOLVE 496S275Wright Medical Technology, Inc. · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall6 reports
- NA 09.405.966SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 03.405.000SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.250SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.263SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.583SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.950SSynthes 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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