BELLATEK® ENCODE® EHA444Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868002925), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.

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

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.

• MalfunctionFeb 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT HE ENCODE DOESN'T FIT. THIS CLINIC EXPERIENCED AN INCOMPATIBILITY BETWEEN THE T3 SHORT AND THE ENCODE ON (B)(6), (B)(6). AS ANOTHER PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6), ZIMVIE JAPAN CHECKED THE AVAILABILITY OF ANOTHER LOT IN THE JAPAN WAREHOUSE, CONFIRMED ITS COMPATIBILITY WITH THE ENCODE, SELECTED A COMPATIBLE BNES505 2120012739, AND DELIVERED IT TO THE CLINIC FOR THE SURGERY SCHEDULED FOR FEBRUARY 7TH. THE DENTIST USED THE LOT ON (B)(6), BUT UNFORTUNATELY THE RESULTS SHOWED THE SAME INCOMPATIBILITY EVENT. DOCTOR USED THA44 INSTEAD OF ENCODE TO COMPLETE THE PROCEDURE. DELAY, IT TOOK TWICE AS LONG AS USUAL. THIS REPORT REFERS TO 07 FEB 2025 EVENT. THE PATIENTS BONE DENSITY WAS TYPE I BONE DENSITY. THE INSERTION TORQUE USED WAS 50N USING THE ENGINE. THE DEPTH WAS THEN ADJUSTED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408533 ↗