LCP 426.652Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982217325), received between Aug 28, 2018 and Aug 28, 2018 — 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 (K000682, K041911, K092609); 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.

• InjuryAug 28, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2018 DUE TO COMMINUTED, SEGMENTAL, PERIPROSTHETIC, LEFT FEMORAL SHAFT FRACTURE. PATIENT WAS IMPLANTED WITH TITANIUM PERIPROSTHETIC PLATES AND SCREW, SYNTHES CABLE SYSTEM, LEFT FEMUR (LISS PLATE PLACEMENT). FRACTURE WAS REDUCED WITH MULTIPLE BONE CLAMPS. A CRUTCH WAS DIRECTED AT THE FRACTURE APEX TO AID IN THE REDUCTION PROCESS. TWO (2) CABLES WERE PLACED AT EITHER END OF THE BUTTERFLY FRAGMENT TO MAINTAIN A REDUCTION. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT COMPLAINED OF A TWINGE FEELING IN HIS LEG. RADIOLOGY IMAGES WERE TAKEN AND REVEALED A BROKEN PLATE AT THE PREVIOUS FRACTURE SITE. ON (B)(6) 2018, PATIENT UNDERWENT REVISION AND HARDWARE REMOVAL SURGERY DUE TO MAL-UNION AND BREAKAGE OF THE PERIPROSTHETIC PLATE. DURING THE PROCEDURE, THE IMPLANTS WERE REMOVED AND REPLACED WITH A NEW PERI-PROSTHETIC PLATE, MULTIPLE 4.5MM CORTICAL AND LOCKING CORTICAL SCREWS, 3 LARGE STAINLESS STEEL SYNTHES CABLES, 2 CORTICAL STRUTS, MULTIPLE CABLES, MIXED 40CC OF CANCELLOUS BONE CHIPS WITH 15CC OF DEMINERALIZED BONE MATRIX (DBX) BONE PUTTY. ALL FRAGMENTS WERE REMOVED WITHOUT COMPLICATIONS. THE SURGERY WAS

  Patient problems: Bone Fracture(s); Discomfort; Failure of Implant; Impaired Healing

  MAUDE report 7823116 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000682, K041911, K092609. 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.