Distal Femur Plate, 21301-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09120034307058), received between May 17, 2022 and May 18, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K093868); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A DISTAL FEMUR PLATE 9-HOLE BENT APPROX. 2 MONTHS POST-OP. DEVICE USED FOR DIAGNOSIS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14427122 ↗
• InjuryMay 18, 2022Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DISTAL FEMUR PLATE 9-HOLE BROKE APPROX. 3 MONTHS POST-OP. DEVICE USED FOR DIAGNOSIS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14427034 ↗
• InjuryMay 17, 2022Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DISTAL FEMUR PLATE 13-HOLE BROKE APPROX. 3 MONTHS POST-OP. DEVICE USED FOR DIAGNOSIS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14426648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093868. One submission often covers many models, so check the product and lot details in each record.

• Z-1603-2026 · Jan 23, 2026 · Open, Classified
  I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301