LCP 445.091Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982223418), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 injury.

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

• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: AO PPFX . CLINICAL ADVERSE EVENT RECEIVED FOR POSTOPERATIVE ADVERSE EVENT: OTHER ¿ SKIN BREAKDOWN OVER HARDWARE. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY RELATED. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: NOT AVAILABLE, BETWEEN 3 TO 12 MONTHS POSTOP. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: CT SCAN, RESULTED IN A MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR FUNCTION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22777566 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. 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,