PRECICE® Plating System LP4.5-SRF40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517021229), received between Aug 3, 2021 and Oct 18, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K192181); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED THAT A BEND DEVELOPED ON THE PLATE DURING THE COURSE OF TREATMENT. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DELAYED UNION. THE SURGEON ELECTED TO KEEP THE HARDWARE IN PLACE FOR THE DURATION OF HEALING.

  Patient problems: Impaired Healing

  MAUDE report 12649952 ↗
• InjuryAug 3, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  CORRECTED LOT NUMBER WAS OBTAINED.

  Patient problems: Osteolysis

  MAUDE report 12269283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192181. One submission often covers many models, so check the product and lot details in each record.

• Z-1325-2021 · Feb 12, 2021 · Open, Classified
  PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.