Distal Femur Plate, 21301-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034307034), received between Jan 9, 2019 and Jan 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SCREWS BACKED OUT OF A DISTAL FEMUR PLATE 5-HOLE POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2016. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016.

  Patient problems: No Information

  MAUDE report 8230467 ↗

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