Peri-Loc 71809006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010523211), received between Feb 8, 2018 and Oct 30, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2018Break; Break

  IT WAS REPORTED THAT A SERIOUS HAS OCCURED. THE PATIENT HAD FOREARM PLATES DONE, HE REPORTED PLATE BROKE. CAUSE IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 8020596 ↗
• MalfunctionOct 29, 2018Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE ULNA PLATE BROKE. NO DELAY, INJURY OR BACK UP REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017295 ↗
• InjuryFeb 8, 2018Fracture; Fracture

  IT WAS REPORTED A REPLACEMENT SURGERY WAS PERFORMED DUE TO THE PLATE SNAPPED IN HALF.

  Patient problems: Injury

  MAUDE report 7251200 ↗

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: