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Legion 71933564

by Smith & Nephew, Inc.

Legion 71933564 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K041106 on 1 Jul 2004 and listed in FDA GUDID since 29 Aug 2015 (UDI-DI 00885556061787), active as of 23 Oct 2026. One FDA recall is 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

None ongoing

1 closed

Documents

510(k) K041106

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556061787 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK041106 Date1 Jul 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041106 decided 1 Jul 2004 Active
  • FDA GUDID UDI-DI 00885556061787 listed 29 Aug 2015 Listed

Recalls

1 recall · FDA

    • 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

3 dated events

  1. Cleared FDA 510(k) K041106
  2. Listed FDA GUDID 00885556061787
  3. Recall initiated FDA recalls Z-0092-2018

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  • Withdrawn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
71933564
Primary DI / UDI-DI
00885556061787
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

Related devices

Category: Knee arthroplasty wedge

Cleared under the same submission (K041106)

and 8 more cleared under K041106

Similar devices in this category

Other devices filed under Knee arthroplasty wedge.

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)