Skip to content

PRECICE® Plating System LP4.5-DRF4BRecalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, Bump · Class 2 · Implant

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
3

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517021762), received between Jul 7, 2021 and Jul 7, 2021 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Patient problems: Bone Fracture(s)

    MAUDE report 12132591 ↗

Other Plate, Fixation, Bone devices

All Plate, Fixation, Bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.