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Peri-Loc 71861013Recalls & reported problems

Smith & Nephew, Inc. · PERI-LOC 3.5MM TITANIUM MEDIAL DISTAL TIBIA PLATE 13 HOLE LEFT · Class 2 · Implant

All models of Peri-Loc (102)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 03596010635860), received between Jan 12, 2018 and Jan 12, 2018 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K083032, K210837, K213126); 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

Device problems

  • Break1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJan 12, 2018Break; Break

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF THE DEVICE.

    Patient problems: Failure of Implant

    MAUDE report 7186521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083032, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

  • Z-0373-2016 · Oct 20, 2015 · Terminated
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
  • Z-0372-2016 · Oct 20, 2015 · Terminated
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate

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