LCP 02.001.324Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982027696), received between Nov 13, 2018 and Dec 19, 2018 — classified as 2 injuries.

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 18, 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.

• InjuryDec 19, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN ADDITIONAL KNEE SURGERY TO REMOVE THE BROKEN PLATE DUE TO NON-UNION OF DISTAL FEMUR AND IMPLANTATION OF AN UNKNOWN FEMORAL NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8180530 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE CONDYLAR PLATE, TWO (2) 4.5MM UNKNOWN CORTEX SCREW, FIVE (5) 5.0MM UNKNOWN CANNULATED LOCKING SCREWS, ONE (1) 7.3MM UNKNOWN CANNULATED LOCKING SCREW AND FOUR (4) UNKNOWN INDEPENDENT LAG SCREWS DUE TO NON-UNION OF DISTAL FEMUR. THERE WAS NO PRODUCT MALFUNCTION REPORTED. REAMER/IRRIGATOR/ASPIRATOR WAS USED TO HARVEST BONE GRAFT AND IMPLANTATION OF ZIMMER RETROGRADE NAIL WAS DONE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND PATIENT OUTCOME WAS AS PLANNED. THIS REPORT IS FOR ONE (1) 4.5MM LCP CURVED CONDYLAR PLATE 14 HOLES. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8066125 ↗

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.