LCP 223.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982158031), received between May 15, 2018 and Apr 2, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684, K082807); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 HARDWARE REMOVAL SURGERY WAS PERFORMED DUE TO INFECTION AND NON-UNION. NO SURGICAL DELAY. ORIGINAL IMPLANT DATE IS UNKNOWN. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE 3.5MM LCP PLATE 12 HOLES 163MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 19024845 ↗
• InjurySep 26, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REPORTED THAT A PATIENT HE HAD OPERATED ON SEVERAL MONTHS AGO HAD UNDERGONE REVISION SURGERY AT ANOTHER FACILITY. THE 3.5 LCP PLATE HAD BROKEN ON AN UNKNOWN DATE. THIS REPORT INVOLVES ONE 3.5MM LCP PLATE 12 HOLES 163MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15485324 ↗
• InjuryJun 14, 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 (42) DEVICES. THIS REPORT IS FOR ONE 3.5MM LCP PLATE 12 HOLES 163MM THIS REPORT IS FOR 12 OF THE 42 DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11991911 ↗
• InjuryFeb 17, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL AND REVISION OF FRACTURE, DUE TO NONUNION, A BROKEN LOCKING COMPRESSION PLATE (LCP) TIBIAL PLATE AND FOUR (4) BROKEN SCREWS. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE LOCKING COMPRESSION PLATE (LCP) TIBIAL PLATE IN (B)(6) OF 2019 AT ANOTHER FACILITY. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. THE BROKEN SHAFTS HAD TO BE TREPHINED BUT WERE REMOVED WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2). THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 12 HOLES 163MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Consequences Or Impact To Patient

  MAUDE report 9716563 ↗
• InjuryDec 26, 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) UNKNOWN 3.5 MM LOCKING SCREW THAT WAS BROKEN AND ONE (1) UNKNOWN 5MM CANNULATED LOCKING SCREW THAT WAS COLD WELDED TO 4.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE 12 HOLES/226MM LEFT DUE TO INFECTION. THE PLATE HAD TO BE CUT AWAY TO REMOVE THE SCREW. ALL IMPLANTS INCLUDING THREE (3) UNKNOWN 5.0 MM CANNULATED SCREWS, SIX (6) UNKNOWN LOCKING SCREWS, FOUR (4) UNKNOWN CORTEX SCREWS, (1) UNKNOWN LOCKING SCREW, AND ONE (1) UNKNOWN CANNULATED SCREW WERE REMOVED SUCCESSFULLY. THERE WAS DIFFICULTY REMOVING THE FRAGMENTS THAT WERE GENERATED FROM THE BROKEN DEVICE AND TREPHINE WAS USED TO REMOVE THE SCREW HEAD. ORIGINAL IMPLANTATION WAS ON (B)(6) 2015, FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT CAPTURES THE POST-OPERATIVE INFECTION AND BROKEN SCREWS. THE INTRA-OPERATIVE EVENT INVOLVING THE PLATE BEING CUT AWAY IS CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A 12-HOLE LOCKING COMPRESSION PLATE. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8196923 ↗
• InjuryMay 15, 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 REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) AND SEVEN (7) 3.5 MM CORTEX SCREWS DUE TO INFLAMMATION, INFECTION, AND NON-UNION. THREE OUT THE SEVEN SCREWS WITH THE PLATE WERE REPORTEDLY BROKEN. DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2017, DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE TIBIA. THE SURGEON USED A TREPHINE TO REMOVE THE BROKEN FRAGMENTS AND INSERTED ANTIBIOTIC BEADS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR A 3.5 MM LCP PLATE 12 HOLES 163 MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Impaired Healing; Inflammation; Unspecified Infection

  MAUDE report 7514153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K082807. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,