LCP 423.571Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982216304), received between Dec 7, 2022 and Dec 7, 2022 — 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 16, 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.

• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE CORTEX SCREWS AND THE PLATE FOR THE DIAPHYSEAL FRACTURE OF THE HUMERUS. THE PATIENT WAS ALLOWED TO MOVE WITHOUT RESTRICTIONS FROM ABOUT SIX MONTHS AFTER THE SURGERY. THE PATIENT COMPLAINED OF PAIN. HOWEVER, X-RAY DID NOT SHOW ABNORMALITY. THE PHYSICIAN FOUND THAT THE CORTEX SCREW WAS BROKEN, AND BACK-OUT OF THE PLATE WAS CONFIRMED. IT IS UNKNOWN WHICH OF THE TWO SCREWS WAS BROKEN. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. THE PLATE WAS REPLACED, AND ILIAC WAS TRANSPLANTED. ACCORDING TO THE SURGEON, THE SCREW BREAKAGE MIGHT HAVE BEEN CAUSED BY UNRESTRICTED MOBILITY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI LCP® PLATE 7 HOLES 98MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15933861 ↗

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,