LCP 04.123.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982110305), received between Aug 24, 2018 and Aug 24, 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 (K082625); 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 24, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A PROXIMAL HUMERUS PLATE DUE TO NON-UNION AND BROKEN PLATE. ORIGINALLY, THE EIGHT (8) HOLE TITANIUM PLATE AND THIRTEEN (13) SCREWS WERE IMPLANTED ON (B)(6) 2017. ALL THE SCREWS WERE INTACT, HOWEVER, TWO (2) LOCKING SCREWS BACKED OUT. THE LAST HUMERUS REVISION FOR THE BROKEN PLATE HAD SIX (6) LOCKING SCREWS, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS IN THE HEAD OF THE PLATE. THE SURGEON TOOK OUT THE PLATE AND APPLIED A NEW PLATE. THERE WAS NO DELAY IN THE COMPLETION OF THE PROCEDURE. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART # 412.1XX, LOT # UNKNOWN, QUANTITY # 4), UNKNOWN CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN LOCKING SCREW (PART #404.8XX, LOT # UNKNOWN, QUANTITY # 6). THIS REPORT IS FOR ONE (1) 3.5MM TI LCP PERIARTIC PROX HUMERUS PL 8 HOLE/199MM/LT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 7814691 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082625. One submission often covers many models, so check the product and lot details in each record.

• Z-0309-2011 · Sep 16, 2010 · Terminated
  3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients wit