NA 234-010-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540754523), received between May 12, 2023 and May 12, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K972233); 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.

• MalfunctionMay 12, 2023Problem with Sterilization; Packaging Problem; Problem with Sterilization; Packaging Problem

  IT WAS REPORTED THAT THERE A BREACH IN THE STERILE BARRIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16922518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972233. One submission often covers many models, so check the product and lot details in each record.

• Z-0837-2018 · Nov 17, 2017 · Terminated
  STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.