Peri-Loc 71801108Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010520661), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 malfunction.

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

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

• MalfunctionJan 13, 2021Unclear Information; Unclear Information

  IT WAS REPORTED THAT IT WAS NOTICED THAT THE DEVICE HAD TWO LABELS INDICATING THE REFERENCE NUMBER AND THE BATCH, BUT TWO SEPARATE EXPIRY DATES (00/09/2019 AND 09/2024). THE LABEL 2024 IS LOCATED UNDER THE FILM WHILE, THE LABEL 2019 IS STUCK ON TOP FOR RE-LABELLING WITH GS1. THE INCONSISTENCY WAS DETECTED BEFORE THE PROCEDURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159272 ↗

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