Peri-Loc 71800013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010520036), received between Sep 7, 2018 and Feb 14, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, PLATE WAS REMOVED IN TWO HALVES, WHICH GENERATED AN OSSEOUS DAMAGE BECAUSE THE FRACTURE UNBUNKED.

  Patient problems: Injury

  MAUDE report 9711143 ↗
• InjurySep 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A PLATE BREAKAGE.

  Patient problems: Injury

  MAUDE report 9135147 ↗
• InjurySep 7, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED SINCE THE PERILOC L-D FEMORAL PLATE HAS BROKEN.

  Patient problems: Injury

  MAUDE report 7856984 ↗

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