CHS 71110024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010173027), received between Apr 19, 2021 and Apr 19, 2021 — 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 (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.

• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PLANNED REVISION SURGERY FOR REMOVAL OF AN IMPLANT (FROM AN UNKNOWN MANUFACTURER), THE TIP OF A RET ROD AMBI/CL WRENCH BROKE. THE BROKEN PIECE REMAINED INSIDE THE MATING PART OF THE IMPLANT INSIDE THE PATIENT. AT THE END, THE IMPLANT WAS NOT EXPLANTED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688989 ↗

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