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CPCS 71312408Recalls & reported problems

Smith & Nephew, Inc. · CPCS DISTAL CENTRALIZER SIZE 8MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010466976), received between Aug 26, 2019 and Aug 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A TUMOR INGRESS.

    Patient problems: Injury

    MAUDE report 8929175 ↗

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