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No Brand XK000708-1

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 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 Number00885556868805 UDI-DI Date2 Feb 2022ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0277-2025 FDA Class II initiated 2 Oct 2024
    • Ongoing Z-0278-2025 FDA Class II initiated 2 Oct 2024

    Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

    • Terminated Z-1951-2021 FDA Class II initiated 19 May 2021

    The device components experienced a manufacturing process error that resulted in surface damage from product handling.

    • Completed Z-2538-2019 FDA Class II initiated 15 Jan 2018

    The affected products were inadvertently packaged with an incorrect screw component.

    • Terminated Z-0816-2016 FDA Class II initiated 18 Jan 2016

    The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.

  • 2 recalls, same reason

    • Terminated Z-1819-2009 FDA Unclassified (pre-2012) initiated 22 Jan 2009
    • Terminated Z-1820-2009 FDA Unclassified (pre-2012) initiated 22 Jan 2009

    Products were mispackaged.

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  • Withdrawn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
Unicondylar knee prosthesis
Model / Ref / Catalog
XK000708-1
Primary DI / UDI-DI
00885556868805
510(k) Number
FDA Product Code
JWH
GMDN Term
Unicondylar knee prosthesis
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Unicondylar knee prosthesis

Cleared under the same submission (K043440)

Show all (12)

Other devices from Smith & Nephew, Inc.

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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