Humeral Head Plate, Wide 21131-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034302992), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K051412); 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 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A HUMERAL HEAD PLATE, WIDE, 3-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2013. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: No Information

  MAUDE report 8225547 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051412. One submission often covers many models, so check the product and lot details in each record.

• Z-1594-2026 · Jan 23, 2026 · Open, Classified
  Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 211