NA 04.402.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982128089), received between Feb 9, 2023 and Feb 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2023Device Slipped; Device Slipped

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 16334514 ↗

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 · Terminated
  Synthes 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 · Terminated
  Synthes 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