Peri-Loc 71801013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010520623), received between Jul 20, 2018 and Nov 28, 2022 — classified as 1 injury, 1 malfunction.

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 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.

• InjuryNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A FRACTURE FIXATION PERFORMED IN THE MONTH OF (B)(6) 2022 UTILIZING A 3.5MM M-D TIB LK PL13H L 223MM, THE DEVICE BROKE. AT THIS POINT, IT IS UNKNOWN IF THE PATIENT EXPERIENCE ANY TRAUMA PRIOR THE ONSET OF THE SYMPTOMS, AND ALSO, IT IS UNKNOWN IF THIS PROBLEM WILL BE INTERVENED; THEREFORE, IT IS UNKNOWN WHETHER A REVISION SURGERY WILL BE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 15875048 ↗
• MalfunctionJul 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THEATRE ON THE (B)(6) 2018 FOR REMOVAL OF THIS METAL WORK. ACCORDING TO THE CONSULTANT, THIS PATIENT SUSTAINED NO INJURY TO HIS LEG; THE PLATE "JUST BROKE". THE CONSULTANT SAID THE "PLATE WAS ONLY IN THE PATIENT FOR ABOUT 6 WEEKS AND IT BROKE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7708430 ↗

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