Legion 71421162

• FDA 510(k) K230653 decided 4 May 2023 Active· +1 more in the status table
• FDA GUDID UDI-DI 03596010543813 listed 30 Aug 2015 Listed

• 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.

• • Ongoing Z-2621-2023 FDA Class II ·initiated 31 Aug 2023

  The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N 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. 22 Jan 2009 Recall initiated FDA recalls Z-1819-2009
2. 22 Jan 2009 Recall initiated FDA recalls Z-1820-2009
3. 30 Aug 2015 Listed FDA GUDID 03596010543813
4. 18 Jan 2016 Recall initiated FDA recalls Z-0816-2016
5. 15 Jan 2018 Recall initiated FDA recalls Z-2538-2019
6. 19 May 2021 Recall initiated FDA recalls Z-1951-2021
7. 4 May 2023 Cleared FDA 510(k) K230653
8. 31 Aug 2023 Recall initiated FDA recalls Z-2621-2023
9. 2 Oct 2024 Recall initiated FDA recalls Z-0277-2025
10. 2 Oct 2024 Recall initiated FDA recalls Z-0278-2025

1 earlier event are in the sections above.

Trade name

Legion

Generic name

Uncoated knee femur prosthesis, metallic

Model / Ref / Catalog

71421162

Primary DI / UDI-DI

03596010543813

510(k) Number

K043440 ↗

K230653 ↗

FDA product code

JWH

GMDN term

Uncoated knee femur prosthesis, metallic

Device class

Class II

Regulation number

888.3560

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Uncoated knee femur prosthesis, metallic

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• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

See all devices from Smith & Nephew, Inc. →