CHS 71115062Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010173614), received between Aug 20, 2020 and Aug 20, 2020 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K093047); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, RETAINING ROD WAS USED TO REMOVE AN AMBI LAG SCREW. DEVICE WAS OVERTIGHTENED AND THE THREADS STRIPPED. PROCEDURE CONCLUDED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW AND WITH A DELAY GREATER THAN 30 MINUTES. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10433941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434