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Legion 71421746

by Smith & Nephew, Inc.

Legion 71421746 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K230653 on 4 May 2023 (1 earlier submission) and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010545169), active as of 23 Oct 2026. 2 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

1 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 Number03596010545169 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230653 decided 4 May 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03596010545169 listed 30 Aug 2015 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • 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-0092-2018 FDA Class II initiated 14 Sep 2017

    The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

Timeline

5 dated events

  1. Cleared FDA 510(k) K041106
  2. Listed FDA GUDID 03596010545169
  3. Recall initiated FDA recalls Z-0092-2018
  4. Cleared FDA 510(k) K230653
  5. Recall initiated FDA recalls Z-2621-2023

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  • Withdrawn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
Knee arthroplasty wedge
Model / Ref / Catalog
71421746
Primary DI / UDI-DI
03596010545169
510(k) Number
FDA product code
JWH
GMDN term
Knee arthroplasty wedge
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K041106)

and 8 more cleared under K041106

Cleared under the same submission (K230653)

and 8 more cleared under K230653

Similar devices

Other devices filed under FDA product code JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER).

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)