Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10886982031617 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

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
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).

1 jurisdiction

United States — GUDID listing Listed

GUDID

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