LPF, LCB 00-0907-4670Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132111949), received between May 31, 2019 and May 31, 2019 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K111086, K260323); 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 18, 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.

• InjuryMay 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT FOLLOWING A DISTAL FEMORAL OSTEOTOMY PROCEDURE, AN IMPLANTED SCREW WAS FOUND TO BE FRACTURED. PATIENT UNDERWENT A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 8659826 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111086, K260323. One submission often covers many models, so check the product and lot details in each record.

• Z-2796-2015 · Jul 28, 2015 · Terminated
  3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.