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PERI-LOC VLP 71821348Recalls & reported problems

Smith & Nephew, Inc. · PERI-LOC VLP 3.5MM X 48MM CORTEX SCREW SEFL TAPPING · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 03596010625595), received between Nov 8, 2019 and Nov 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K062216); 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 18, 2026.

Most reported problems

Device problems

  • Off-Label Use1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 8, 2019Off-Label Use; Off-Label Use

    IT WAS REPORTED THAT THE ITEM HAD THE WRONG ITEM NUMBER ON THE PACKAGE. THIS WAS DISCOVERED AFTER THE CASE. NO PATIENT AFFECTATION OR DELAYS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9295887 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062216. One submission often covers many models, so check the product and lot details in each record.

  • Z-1854-2017 · Mar 9, 2017 · Terminated
    Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page