Peri-Loc 71829314Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010527646), received between Apr 9, 2022 and Jun 20, 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 (K033669, 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.

• InjuryJun 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION REVISION SURGERY PERFORMED ON (B)(6) 2021 THE PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2021 TO REMOVE THE INSERTED PERI-LOC 4.5MM LOCKING COMPRESSION PLATE 14 HOLE 265MM DUE TO FRACTURE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14742808 ↗
• InjuryApr 9, 2022Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A BREAK. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE 4.5MM LCK COMP PL 14H 265MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 14068177 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033669, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-2314-2010 · Jul 20, 2010 · Terminated
  PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: