The Big Easy® 1156602Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902848209), received between Mar 16, 2022 and Mar 16, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K002897); 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.

• MalfunctionMar 16, 2022Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PISTON BROKE WHILST BEING CRIMPED. THE BROKEN IMPLANT WAS RETRIEVED AND ANOTHER ONE WAS IMPLANTED. THE PRODUCT HAD CONTACT WITH THE PATIENT. IT WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. THE REPORTED EVENT RESULTED IN A PROCEDURE DELAY/EXTENDED TIME OF 5 MINUTES. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13786183 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002897. One submission often covers many models, so check the product and lot details in each record.

• Z-2284-2013 · Aug 23, 2013 · Terminated
  Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.