VA-LCP 04.111.630Recalls & reported problems
Synthes GmbH · 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 6H HD/3H SHAFT/RT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982101822), received between Apr 5, 2021 and Apr 4, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K083694); 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
- Break2
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, DURING SURGERY THE SOCKET WRENCH WITH STRAIGHT HANDLE BROKE AND SPLIT AT THE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 6H HD/3H SHAFT/RT. THIS IS REPORT 1 OF 2 FOR COMPLAINT PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673533 ↗InjuryApr 5, 2021Break; Material Twisted/Bent; No Apparent Adverse Event; Break; Material Twisted/Bent; No Apparent Adverse Event
IN THE FOLLOW-UP REPORT 1, IT WAS REPORTED INADVERTENTLY THAT THE COMPLAINT IS NOT REPORTABLE. THE INITIAL COMPLAINT WAS REVIEWED AGAIN AND FOUND REPORTABLE. THE CUSTOMER REPORTED THAT THE PLATE BROKE POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 11614789 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083694. One submission often covers many models, so check the product and lot details in each record.
- Z-2087-2013 · Jul 30, 2013 · TerminatedSynthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the dista
- Z-2057-2013 · May 31, 2013 · TerminatedSynthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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