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PCD 0506486000Recalls & reported problems

Stryker Corporation · Precision System without Needle · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540518095), received between Dec 19, 2018 and Dec 19, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Tear, Rip or Hole in Device Packaging2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 19, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED BY THE CUSTOMER THAT THE STERILITY OF THE DEVICE PACKAGING IS BEING COMPROMISED BY A LOOSE ITEM INSIDE OF THE BOX. THERE WAS NO ASSOCIATED PROCEDURE AND THEREFORE, NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8178693 ↗
  • MalfunctionDec 19, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED BY THE CUSTOMER THAT THE STERILITY OF THE DEVICE PACKAGING IS BEING COMPROMISED BY A LOOSE ITEM INSIDE OF THE BOX. THERE WAS NO ASSOCIATED PROCEDURE AND THEREFORE, NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8178692 ↗

Other MIXER, CEMENT, FOR CLINICAL USE devices

All MIXER, CEMENT, FOR CLINICAL USE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.