VA-LCP 04.111.640SRecalls & reported problems
Synthes GmbH · 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER · Class 2 · Implant
All models of VA-LCP (256)
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 10886982101877), received between Aug 24, 2022 and Aug 24, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant1
- Muscle/Tendon Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE ORIF SURGERY WITH TCP IMPLANTS FOR FRACTURE OF DISTAL RADIUS. AFTER THE SURGERY IN EARLY (B)(6) OF 2022, THE PATIENT REPORTED THAT HER THUMB DID NOT MOVE, A RUPTURED FLEXOR POLLICIS LONGUS TENDON WAS SUSPECTED. ON (B)(6) 2022, PLATE REMOVAL AND TENDON GRAFT SURGERY WERE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant; Muscle/Tendon Damage
MAUDE report 15282416 ↗
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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