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Genesis II 71420346

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 Number03596010207166 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2774-2020 FDA Class II initiated 16 Jul 2020

    Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

    • Terminated Z-1418-2022 FDA Class II initiated 27 Jun 2022

    The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

    • Terminated Z-2883-2018 FDA Class II initiated 1 Aug 2017

    Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

    • Terminated Z-0573-2016 FDA Class II initiated 9 Nov 2015

    One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

  • 2 recalls, same reason

    • Terminated Z-0130-2014 FDA Class II initiated 7 Oct 2013
    • Terminated Z-0131-2014 FDA Class II initiated 7 Oct 2013

    Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Genesis II
Generic Name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
71420346
Primary DI / UDI-DI
03596010207166
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 (K951987)

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