REDAPT 71355015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556219546), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

1 other recall cover devices cleared under the same FDA submission (K121627); 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.

• InjuryJun 5, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT DISTAL REAMER 240MM SIZE 17 GOT STUCK WHILE REAMING. AN ETO WAS PERFORMED TO THE FEMUR TO REMOVE THE DISTAL REAMER. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 22155750 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121627. One submission often covers many models, so check the product and lot details in each record.

• Z-0944-2017 · Nov 15, 2016 · Terminated
  Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments