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Peri-Loc 71801010Recalls & reported problems

Smith & Nephew, Inc. · 3.5MM MED DISTAL TIBIA LOCKING PLATE 10 HOLE LEFT 185MM · 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 03596010520616), received between Jan 19, 2024 and Jan 19, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K092015, 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

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

  • InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON LITERATURE REVIEW "EFFECT OF SURGICAL FIXATION ON THE RATE OF FRACTURE HEALING AND BONE DENSITY OF PAHENTT WITH OPEN AND COMMINUTED FRACTURE OF EXTREMITIES", 3 PATIENTS HAD A BONE NONUNION AFTER A PROCEDURE FOR FRACTURE TREATMENT USING A PERI-LOC PERIARTICULAR LOCKING PLATING SYSTEM. IT IS UNKNOWN HOW THE EVENTS WERE TREATED. PATIENTS OUTCOME ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 18544972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092015, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

  • Z-2036-2017 · Mar 22, 2017 · Terminated
    PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116

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