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Legion 71453223

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization 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 StatesGUDID listing Number00885556033425 UDI-DI Date28 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

6 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-1507-2020 FDA Class II initiated 19 Dec 2019

    LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

  • 4 recalls, same reason

    • Terminated Z-1905-2018 FDA Class II initiated 30 Mar 2018
    • Terminated Z-1907-2018 FDA Class II initiated 30 Mar 2018
    • Terminated Z-1906-2018 FDA Class II initiated 30 Mar 2018
    • Terminated Z-1904-2018 FDA Class II initiated 30 Mar 2018

    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Legion
Generic name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
71453223
Primary DI / UDI-DI
00885556033425
510(k) Number
FDA product code
JWH
GMDN term
Uncoated knee tibia prosthesis, polyethylene
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K071071)

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Cleared under the same submission (K230653)

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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