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Legion 71421205

by Smith & Nephew, Inc.

Legion 71421205 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K230653 on 4 May 2023 (2 earlier submissions) and listed in FDA GUDID since 28 Sep 2015 (UDI-DI 00885556030622), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230653 Date4 May 2023DecidedStatusActive
United StatesGUDID listing Number00885556030622 UDI-DI Date28 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230653 decided 4 May 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00885556030622 listed 28 Sep 2015 Listed

Recalls

8 recalls · 3 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.

    • 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.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-1820-2009
  2. Cleared FDA 510(k) K093746
  3. Listed FDA GUDID 00885556030622
  4. Recall initiated FDA recalls Z-0816-2016
  5. Recall initiated FDA recalls Z-2538-2019
  6. Recall initiated FDA recalls Z-1951-2021
  7. Cleared FDA 510(k) K230653
  8. Recall initiated FDA recalls Z-2621-2023
  9. Recall initiated FDA recalls Z-0277-2025
  10. Recall initiated FDA recalls Z-0278-2025

2 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Legion
Generic name
Unicondylar knee prosthesis
Model / Ref / Catalog
71421205
Primary DI / UDI-DI
00885556030622
510(k) Number
FDA product code
JWH
GMDN term
Unicondylar knee prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Unicondylar knee prosthesis

Cleared under the same submission (K043440)

and 8 more cleared under K043440

Cleared under the same submission (K093746)

and 8 more cleared under K093746

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)