Peri-Loc 71860110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010640185), received between Aug 28, 2017 and Sep 22, 2021 — classified as 2 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K083032, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A FRACTURE FIXATION WITH PERI-LOC 4.5MM TI L-D FEM PL 10H R 230MM, A NON-UNION WITH PLATE FRACTURE WAS REPORTED. AN UNPLANNED REVISION SURGERY WAS PERFORMED TO ADDRESS THIS EVENT. AFTER REVISION SURGERY SUBSEQUENT UNION WAS REPORTED. ADDITIONAL DETAILS ARE UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12512781 ↗
• InjuryAug 28, 2017Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE PERI-LOC PLATE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6824669 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083032, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2016 · Oct 20, 2015 · Terminated
  Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
• Z-0373-2016 · Oct 20, 2015 · Terminated
  Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate