Peri-Loc 71801411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010573667), received between Feb 26, 2019 and Feb 26, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT THE PLATE ON THE PATIENT BROKE ON A FALL. A REVISION SURGERY HAD TO BE PERFORMED TO REPLACE THE BROKEN PLATE FOR A NAIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372671 ↗
• InjuryFeb 26, 2019Break; Break

  IT WAS REPORTED THAT THE PLATE WAS INSERTED ON (B)(6) 2018. PATIENT RECENTLY HAD A FALL AND (POSSIBLY) CONSEQUENTLY THE PLATE WAS DISCOVERED TO BE BROKEN. SURGEON BELIEVES THE PLATE BROKE DURING THE FALL AND THIS SHOULD NOT HAPPEN. BROKEN PLATE WAS REMOVED AND REPLACED WITH A NAIL.

  Patient problems: Injury

  MAUDE report 8371667 ↗

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