Skip to content

No Brand XK000696-3

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 closed

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 Number00885556867075 UDI-DI Date6 Dec 2021ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

    • 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  • Withdrawn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
No Brand
Generic Name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
XK000696-3
Description
GII CR DEEP DISH INSERT W/ JOURNEY LOCK SIZE 0 9MM
Primary DI / UDI-DI
00885556867075
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

Related devices

Category: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K071071)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • 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