LCP 02.123.025Recalls & reported problems
Synthes GmbH · 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 6 HOLE/163MM/LT · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982042132), received between Jun 26, 2018 and Jun 26, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH A BONE MARROW ASPIRATE CONCENTRATE BONE GRAFT IMPLANT WAS TREATED FOR NONUNION OF THE HUMERUS WITH A LOCKING COMPRESSION PLATE (LCP) AND UNKNOWN SCREWS ON AN UNKNOWN DATE. THE PATIENT THEN BEGAN EXPERIENCING PAIN AND EVENTUALLY, THE SCREW HEADS BROKE OFF IN THE DISTAL PORTION OF THE LCP. THE PATIENT WAS THEN REVISED ON AN UNKNOWN DATE TO A PROXIMAL HUMERUS PLATE AFTER THE HUMERUS WAS SHORTENED A LITTLE TO ENSURE GOOD BONE CONTACT AND 10CC OF VIVIGEN WAS IMPLANTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOMES WERE UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 7637277 ↗
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 · Terminated3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients wit
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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