PRECICE® Plating System LP4.5-PLF4BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517021526), received between Jun 8, 2021 and Aug 12, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (3 reports).

3 FDA recall records name this device's identifier, 3 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 29, 2021Open, Classified

   The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

   Z-0319-2022 · Root cause: Device Design · FDA record ↗

2. Feb 12, 2021Open, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1325-2021 · Root cause: Under Investigation by firm · FDA record ↗

3. Feb 12, 2021Open, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1323-2021 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryAug 12, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT UPON EXPLANT, CORROSION WAS NOTED AROUND THE PLATE'S MALE/FEMALE JUNCTION. AT THE TIME OF THE REMOVAL BRIDGING BONE WAS PRESENT, HOWEVER, OSTEOLYSIS AND SCALLOPING OF THE REGENERATE BONE OCCURRED IN CLOSE PROXIMITY TO THE CORRODED PLATE JUNCTION IN THE FEMUR.

  Patient problems: Osteolysis

  MAUDE report 12315264 ↗
• InjuryJul 13, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT A REVISION OCCURRED DUE TO A FEMORAL NON-UNION. AS PER THE REPORTER, UPON EXPLANT CORROSION WAS DISCOVERED ON THE PLATE AND WAS MOST VISIBLE AROUND THE SCREW HOLES. THE SURGEON BELIEVES THAT THE CORROSION FORMATION MAY HAVE BEEN ASSISTED BY WEAR DEBRIS GENERATED BY PATIENT WEIGHT-BEARING.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12161085 ↗
• MalfunctionJun 8, 2021Corroded; Corroded

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959740 ↗