2.4mm Va-Lcp Intercarpal Fusion System

510(k) K103243

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK103243	Date21 Jan 2011Cleared	StatusActive

7 recalls · FDA

5 recalls, same reason
- Terminated Z-0880-2020 FDA Class II initiated 16 Dec 2019
- Terminated Z-0881-2020 FDA Class II initiated 16 Dec 2019
- Terminated Z-0882-2020 FDA Class II initiated 16 Dec 2019
- Terminated Z-0879-2020 FDA Class II initiated 16 Dec 2019
- Terminated Z-0883-2020 FDA Class II initiated 16 Dec 2019
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
- 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 on shared 510(k) K103243
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).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)