NA 02.226.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982058102), received between Jun 20, 2022 and Jun 20, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K050636, K161616); 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.

• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT THE PATIENT IS HAVING AN ADVERSE REACTION (POSSIBLE METAL ALLERGY) TO OUR STAINLESS STEEL FIRST MTP FUSION PLATE AND STAINLESS 3.0 HEADLESS COMPRESSION SCREW . NO REMOVAL OR REVISION SURGERY HAS BEEN DONE. PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 3.0 HDLESS COMP SCR-SHORT THREAD 34. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14744421 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050636, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-0238-2019 · Sep 12, 2018 · Terminated
  3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-