Peri-Loc 71800016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010520043), received between Oct 12, 2018 and Nov 7, 2022 — classified as 2 injuries.

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

• InjuryNov 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY WAS PERFORMED TWO YEARS AGO, THE 4.5MM L-D FEM LK PL16H L 342MM BROKE WITHOUT ANY EXTERNAL FORCE. PATIENT HAS UNDERGONE REVISION SURGERY. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 15747889 ↗
• InjuryOct 12, 2018Break; Break

  IT WAS REPORTED A DISTAL LOCKING PLATE HAS BROKEN INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT.

  Patient problems: Injury

  MAUDE report 7962892 ↗

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