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Va-Lcp 04.111.721

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982102102 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2087-2013 FDA Class II initiated 30 Jul 2013

    The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.

    • Terminated Z-2057-2013 FDA Class II initiated 31 May 2013

    The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Va-Lcp
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
04.111.721, 04111721
Primary DI / UDI-DI
10886982102102
510(k) Number
FDA Product Code
HRS
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K083694)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No