ECHELON 71310112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010328519), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionJan 27, 2021Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE OUTER PACKAGE OF THE ECH CEM FEM SZ 12 175MM WAS OPENED A LONG BLACK HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE NEXT LEVEL OF STERILE PACKAGE WAS THEN OPENED ONTO THE STERILE FIELD. THIS WAS INSPECTED AND WAS FOUND ACCEPTABLE TO USE, PROCEDURE WAS COMPLETED USING THE SAME DEVICE. HAIR WAS IN OUTER STERILE PACKAGE, NOT WITHIN STERILE INNER PACKAGE. SO IT NEVER CONTACTED IMPLANT. THIS HAPPENED DURING THR PROCEDURE, THERE WAS A DELAY OF LESS THAN 30 MIN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11235593 ↗

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.