Pilon Plate, Wide 21091-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034303128), received between Jan 7, 2019 and Jan 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K052011); 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 16, 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 7, 2019Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A PILON PLATE WIDE 4-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE WAS (B)(6) 2010. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: No Information

  MAUDE report 8221907 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052011. One submission often covers many models, so check the product and lot details in each record.

• Z-1596-2026 · Jan 23, 2026 · Open, Classified
  Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 2131