Peri-Loc 71800019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010520050), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 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.

• MalfunctionFeb 24, 2021Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE PACKAGING OF THE 4.5MM L-D FEM LK PL19H L 399MM WAS FOUND SPLIT AND THE STERILE BARRIER WAS COMPROMISED. IT WAS NOTED PRIOR TO GIVING IT TO THE SCRUB NURSE, INTO THE STERILE FIELD. THERE WAS A S&N BACK UP DEVICE OF THE SAME CONFIGURATION AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY. NO INJURIES INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371605 ↗

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