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Legion 71423222

by Smith & Nephew, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

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 Number03596010608338 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

4 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.

  • 3 recalls, same reason

    • Terminated Z-0590-2015 FDA Class II initiated 4 Nov 2014
    • Terminated Z-0591-2015 FDA Class II initiated 4 Nov 2014
    • Terminated Z-0589-2015 FDA Class II initiated 4 Nov 2014

    The stem taper on this device is undersized; the gauge point is not deep enough.

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  • Withdrawn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
Uncoated knee femur prosthesis, metallic
Model / Ref / Catalog
71423222
Primary DI / UDI-DI
03596010608338
510(k) Number
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

Related devices

Category: Uncoated knee femur prosthesis, metallic

Cleared under the same submission (K060742)

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Cleared under the same submission (K230653)

Show all (12)

Other devices from Smith & Nephew, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No