PRECICE® Plating System LP4.5-SLF40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517021267), received between May 26, 2021 and Nov 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT UPON EXPLANT THE PLATE WAS NOTED TO HAVE VISIBLE CORROSION AROUND THE PLATE'S LOCKING SCREW HOLES.

  Patient problems: Failure of Implant

  MAUDE report 12897377 ↗
• MalfunctionOct 13, 2021Unstable; Material Twisted/Bent; Unstable; Material Twisted/Bent

  INFORMATION WAS RECEIVED THAT TWO AND A HALF WEEKS POST-OP IT WAS DISCOVERED THAT THE PLATE HAD DISENGAGED. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A SLIGHT BEND IN THE PLATE. NO PATIENT ADVERSE EVENT WAS REPORTED. REPORT 1 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12628377 ↗
• MalfunctionMay 26, 2021Corroded; Material Discolored; Corroded; Material Discolored

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11888504 ↗

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.