LCP 02.111.901Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982032478), received between Jan 9, 2018 and Jan 9, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113364); 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.

• InjuryJan 9, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ULNAR SHORTENING PROCEDURE IN (B)(6) 2017. POST-OPERATIVELY PATIENT HAD NON-UNION AND A PLATE BROKE IN PATIENT. FUTURE REVISION SURGERY PLAN IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 202.216, LOT # UNKNOWN, QUANTITY 6). THIS REPORT IS FOR ONE (1) 2.7MM LCP ULNA OSTEOTOMY PLATE 8 HOLES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7176667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113364. One submission often covers many models, so check the product and lot details in each record.

• Z-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon