LCP 02.001.320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982027658), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K041911); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE AND SEVERAL SCREWS BROKE. IT WAS ALSO DETERMINED THE PATIENT HAD A NON-UNION FRACTURED. THERE WERE ALSO SEVERAL SCREWS IMPLANTED WITH THE PLATE THAT WERE BROKEN. THIS REPORT IS FOR A LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10780153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041911. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.