LC-DCP 243.586Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982169181), received between Sep 23, 2020 and Jun 11, 2021 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K001941); 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.

• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION OF A MIDSHAFT NONUNION IN THE LEFT HUMERUS AND RIGHT TIBIA. IN PATIENT'S HUMERUS, DYNAMIC COMPRESSION PLATES WITH LIMITED BONE CONTACT (LC-DCP) AND NARROW DYNAMIC COMPRESSION PLATES WITH LIMITED BONE CONTACT (LC-DCP) WERE REMOVED, ALONG WITH TWELVE CORTEX SCREWS. PATIENT WAS REVISED TO A NEW LCDCP LARGE FRAGMENT PLATE AND BONE GRAFT HARVESTED FROM THE PATIENT¿S TIBIA. IN PATIENT'S TIBIA, LOCKING COMPRESSION PLATE (LCP) AND LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WERE REMOVED, ALONG WITH TWENTY-ONE CORTEX SCREWS. A RIA WAS USED IN THE TIBIA TO RETRIEVE BONE GRAFT. SURGEON CORRECTED THE DEFORMITY, AND PATIENT¿S TIBIA WAS REVISED WITH A TIBIAL NAIL ADVANCED, AND PLACEMENT OF NEW SCREWS IN REMAINING TWO PLATES. FRAGMENT WERE GENERATED AND WAS REMOVED EASILY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FIVE MINUTES SURGICAL DELAY. THIS COMPLAINT INVOLVES FORTY-TWO (42) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM LC-DCP PLATE 6 HOLES/39MM THIS REPORT IS FOR 5 OF 10 OF THE 42 DEVICES

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11987819 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO TIBIAL MALUNION. ORIGINALLY, IT WAS IMPLANTED ON (B)(6) 2019. THE PLATE AND SCREWS IN FIBULA REMAINED IN PLACE FROM ORIGINAL SURGERY. THE REVISION WAS COMPLETED WITH OSTEOTOMY. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME AFTER THE PROCEDURE WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.0MM LC-DCP® PLATE 6 HOLES/39MM. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS (B)(4) WILL CAPTURES THE TWO (2) PLATES, ONE (1) UNK - SCREWS: METAPHYSEAL AND SEVEN (7) UNK - SCREWS: CORTEX, (B)(4) WILL CAPTURES FOUR (4) UNK - SCREWS: METAPHYSEAL AND SIX (6) UNK - SCREWS: CORTEX WHILE (B)(4) CAPTURES SIX UNK - SCREWS: CORTEX FOR POST-OPERATIVE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 10573275 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001941. One submission often covers many models, so check the product and lot details in each record.

• Z-0406-2014 · Jul 30, 2013 · Terminated
  Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.