Peri-Loc 71173542Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010519689), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 malfunction.

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.

• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE WHILE INSERTING A TROCAR. AN IDENTICAL BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY TIME WAS NOT EXTENDED MORE THAN 30 MIN. THE PATIENT OR SURGICAL PROCEDURE WAS NOT AFFECTED IN ANY WAY DUE TO THE PROBLEM. NO BROKEN PIECES FELL INTO THE PATIENT¿S WOUND. THERE ARE NO PHOTOS AVAILABLE. LOT NUMBER IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739314 ↗

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