LCP 223.641Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982158062), received between Dec 19, 2018 and May 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH THE LCP PLATES 3.5, IN THE ANKLE, WITH BUTTON SUTURE ADJUNCTIVE FIXATION DEVICE (FIBULINK). AT SIX (6) WEEKS POST-OP THE PATIENT EXPERIENCED IMPLANT PROMINENCE. AT 36 WEEKS POST-OP THE PATIENT UNDERWENT HARDWARE REMOVAL OF THE PLATE AND SCREWS. THE PATIENT HAS RECOVERED. THIS REPORT INVOLVES ONE (1) 3.5MM LCP PLATE 14 HOLES 189MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19277524 ↗
• InjuryMay 9, 2024Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH LCP PLATES 3.5, IN THE ANKLE, WITH NO ADJUNCTIVE FIXATION DEVICE. 12 WEEKS POST-OP THE PATIENT EXPERIENCED IMPLANT PROMINENCE. AT 24 WEEKS POST-OP THE PLATE AND SCREWS WERE REMOVED. THE PATIENT HAS RECOVERED. THIS REPORT INVOLVES ONE (1) 3.5MM LCP PLATE 14 HOLES 189MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19277116 ↗
• InjuryDec 19, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH A ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON NOVEMBER 27, 2018. ACTION TAKEN WAS IRRIGATION AND DEBRIDEMENT. HARDWARE REMOVAL OCCURRED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A 3.5MM LCP PLATE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8180283 ↗

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,