LCP 223.551Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982157898), received between Sep 19, 2017 and Jul 20, 2018 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2018 DUE TO OSTEOMYELITIS. AFTER THE SUCCESSFUL HEALING OF THE PATIENT'S FRACTURE, ONE (1) TITANIUM CANNULATED TIBIAL NAILS-EX WITH PROXIMAL BEND, SIX (6) UNKNOWN DISTAL 5.0MM LOCKING SCREWS, ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE AND FOUR (4) UNKNOWN 3.5MM LOCKING SCREWS HAD TO BE REMOVED. ORIGINAL IMPLANT DATE WAS UNKNOWN. THE OSTEOMYELITIS WAS REPORTED AS CELLULITIS, AS THIS IS A BACTERIAL SKIN INFECTION, THE REPORTER WAS UNAWARE OF THE SOURCE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 5 HOLES 72MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7706708 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUESTED THAT ALL HIS HARDWARE BE REMOVED DUE TO PAIN. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016 FOR A LEFT RADIUS AND ULNA FRACTURES AND A LEFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT. ALL THE BONES WERE HEALED AND THE HARDWARE WAS REMOVED FULLY INTACT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS STABLE FOLLOWING SURGERY. THIS REPORT IS FOR ONE (1) 3.5 MM LCP PLATE. THIS IS REPORT 4 OF 11 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 6877612 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUESTED THAT ALL HIS HARDWARE BE REMOVED DUE TO PAIN. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016 FOR A LEFT RADIUS AND ULNA FRACTURES AND A LEFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT. ALL THE BONES WERE HEALED AND THE HARDWARE WAS REMOVED FULLY INTACT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS STABLE FOLLOWING SURGERY. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE. THIS IS REPORT 3 OF 11 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 6877467 ↗

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,