Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00885556062722 UDI-DI	Date29 Aug 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK043440	Date18 Feb 2005Decided	StatusActive

Recalls

7 recalls · 2 ongoing · FDA

2 recalls, same reason
- Ongoing Z-0277-2025 FDA Class II initiated 2 Oct 2024
- Ongoing Z-0278-2025 FDA Class II initiated 2 Oct 2024
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- Terminated Z-1951-2021 FDA Class II initiated 19 May 2021
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
- Completed Z-2538-2019 FDA Class II initiated 15 Jan 2018
The affected products were inadvertently packaged with an incorrect screw component.
- Terminated Z-0816-2016 FDA Class II initiated 18 Jan 2016
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
2 recalls, same reason
- Terminated Z-1819-2009 FDA Unclassified (pre-2012) initiated 22 Jan 2009
- Terminated Z-1820-2009 FDA Unclassified (pre-2012) initiated 22 Jan 2009
Products were mispackaged.

1 jurisdiction

United States — FDA 510(k) Active

GUDID

Show all (12)