LCP 02.124.216Recalls & reported problems
Synthes GmbH · 3.5MM LCP PROXIMAL TIBIA PLATE LOW BEND 12 HOLES/180MM/RIGHT · Class 2 · Implant
All models of LCP (367)
Data updated Oct 16, 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 10886982042613), received between Jan 17, 2019 and Jan 17, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE. THIS IS REPORT 1 OF 11 FOR (B)(4).
Patient problems: Unspecified Infection
MAUDE report 8258558 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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