Peri-Loc 71807085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010522894), received between Aug 24, 2024 and Aug 24, 2024 — classified as 1 injury.

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

• InjuryAug 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ON (B)(6) 2018 ORIF PROCEDURE DUE TO TREAT A RIGHT FEMORAL SHAFT FRACTURE WITH AN INTRAMEDULLARY DEVICE AND DISTAL PLATE. THE DEVICES USED WERE A TRIGEN FEMORAL NAILING SYSTEM AND A PERILOC PLATING SYSTEM. ON (B)(6) 2019, THE PATIENT REPORTED SWELLING OF THE KNEE AND RADIOLOGY RESULTS INDICATED PARTIAL BACKING OUT OF MEDIAL TO LATERAL DISTAL INTERLOCKING SCREW IN NAIL AND BREAKAGE OF MOST PROXIMAL OF THE DISTAL INTERLOCKING SCREWS IN NAIL. ON (B)(6) 2019, RADIOLOGY RESULTS INDICATED BREAKAGE OF MOST DISTAL SCREW IN PLATE. ON (B)(6) 2019, NON UNION OF THE FRACTURE WAS DIAGNOSED. ON (B)(6) 2020, SWELLING CONTINUED AND A HEMATOMA WAS DETECTED. RADIOLOGY RESULTS INDICATED COMPLETE BACKING OUT OF LATERAL TO MEDIAL SCREW IN NAIL WITH HEAD OF SCREW JUST UNDER THE SKIN. ON THIS SAME DAY, THE PROMINENT SCREW WAS EXTRACTED UNDER LOCAL ANESTHESIA. OVERALL, ALIGNMENT WAS MAINTAINED WITH CALLUS FORMATION, BUT HEALING WAS NOT COMPLETE (NONUNION). THE SCREW WAS REMOVED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOM

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

  MAUDE report 20058965 ↗

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: