NA 09.402.424SRecalls & reported problems
Synthes (U.S.A.) LP · 24MM COCR RADIAL HEAD 4MM HT EXTENSION/17.0MM-STER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982132727), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K112030); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A CLOSED PROXIMAL DISPLACED FRACTURE HEAD OF THE LEFT RADIUS. PATIENT WAS IMPLANTED WITH ONE (1) 8 MM STRAIGHT RADIAL STEM 28 MM AND ONE (1) 24 MM RADIAL HEAD 4 MM HEIGHT EXTENSION/17.0 MM. ON (B)(6) 2017 DURING A POSTOPERATIVE FOLLOW UP VISIT, PATIENT PRESENTED WITH PAIN AND LOOSENING OF HARDWARE. REVISION SURGERY HAS BEEN SCHEDULED FOR SOME TIME IN (B)(6) 2017. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Pain
MAUDE report 7087233 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K112030. One submission often covers many models, so check the product and lot details in each record.
- Z-1124-2017 · Dec 29, 2016 · TerminatedSynthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
- Z-1238-2013 · Feb 22, 2013 · TerminatedSynthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and
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 09.405.570SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
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
- 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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