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PCD 0506483000Recalls & reported problems

Stryker Corporation · Precision System with Needle · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540907011), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

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 Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 23, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTED FOUND TO HAVE A TEAR, RIP, OR HOLE IN THE DEVICE PACKAGING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Patient Involvement

    MAUDE report 8816613 ↗

Other MIXER, CEMENT, FOR CLINICAL USE devices

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