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Attune 1506-40-009

by Depuy (Ireland)

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 Number10603295042839 UDI-DI Date5 Dec 2016ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0632-2022 FDA Class II initiated 5 Jan 2022
    • Terminated Z-0631-2022 FDA Class II initiated 5 Jan 2022

    May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

    • Terminated Z-2348-2021 FDA Class II initiated 1 Jul 2021

    Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

  • 2 recalls, same reason

    • Terminated Z-1703-2018 FDA Class II initiated 16 Apr 2018
    • Terminated Z-1704-2018 FDA Class II initiated 16 Apr 2018

    There may be burrs on the extraction hole threads.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Attune
Generic Name
Uncoated knee tibia prosthesis, metallic
Model / Ref / Catalog
1506-40-009, 150640009
Primary DI / UDI-DI
10603295042839
510(k) Number
FDA Product Code
MBH, JWH
GMDN Term
Uncoated knee tibia prosthesis, metallic
Device Class
Class II
Regulation Number
888.3565, 888.3560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

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Category: Uncoated knee tibia prosthesis, metallic

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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