ECHELON 71340212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010328816), received between Mar 13, 2020 and Mar 13, 2020 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K211176, K983834); 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.

• InjuryMar 13, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS PLACED ON PATIENT ON (B)(6) 2019 AND IN (B)(6) 2020 THE DEVICE BROKE INSIDE THE PATIENT. ACCORDING TO THE PHYSICIAN, THE PATIENT DIDN´T PERFORM ANY MOVEMENT OR ACTIVITY THAT COULD CAUSE THE RUPTURE OF THE DEVICE. PATIENT IS STABLE AND WAITING FOR THE REVISION SURGERY THAT WILL BE PERFORMED ON (B)(6) 2020.

  Patient problems: Injury

  MAUDE report 9828838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K983834. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.