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Va-Lcp 04.111.630KS

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 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 Number10886982261601 UDI-DI Date6 Apr 2017ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

    • Terminated Z-2389-2016 FDA Class II initiated 28 Jun 2016

    It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.

    • Terminated Z-0323-2016 FDA Class II initiated 2 Nov 2015

    It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

    • 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

    • Terminated Z-0489-2007 FDA Unclassified (pre-2012) initiated 5 Dec 2006

    Hole is malformed, leading to reduced construct strength.

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  • Withdrawn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
04.111.630KS, 04111630KS
Primary DI / UDI-DI
10886982261601
510(k) Number
FDA Product Code
HRS, HWC
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

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Cleared under the same submission (K083694)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

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