HydroSet XT 897005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327064278), received between Jul 25, 2019 and Jul 25, 2019 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 15, 2018Terminated

   Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19

   Z-0678-2019 · Root cause: Labeling mix-ups · FDA record ↗

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.

• MalfunctionJul 25, 2019Use of Device Problem; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT DURING A PRIMARY PROCEDURE FOR A LEFT CALCANEUS FRACTURE, THAT HYDROSET XT (5 CC) ¿HARDENED SOLID¿ AFTER APPROXIMATELY 90 TO 105 SECONDS AND "A LOT" OF FORCE WAS NEEDED TO GET THE LIQUID OUT OF ITS CONTAINER AND INTO THE POWDER. THE PROCEDURE CALLED FOR A PLATE AND HYDROSET XT WAS INTENDED TO FILL ANY REMAINING CRACKS; HOWEVER, IT WAS DECIDED BY THE SURGEON TO DISCONTINUE USE OF HYDROSET XT DUE TO PREMATURE HARDENING OF THE COMPONENT. THIS RESULTED IN A SURGICAL DELAY OF 4-5 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826116 ↗