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Na 5460-18-000

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 Number10603295174363 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1687-2011 FDA Unclassified (pre-2012) initiated 27 Jan 2011 on shared 510(k) K800894
    • Terminated Z-1686-2011 FDA Unclassified (pre-2012) initiated 27 Jan 2011 on shared 510(k) K800894
    • Terminated Z-1689-2011 FDA Unclassified (pre-2012) initiated 27 Jan 2011 on shared 510(k) K800894
    • Terminated Z-1688-2011 FDA Unclassified (pre-2012) initiated 27 Jan 2011 on shared 510(k) K800894
    • Terminated Z-1690-2011 FDA Unclassified (pre-2012) initiated 27 Jan 2011 on shared 510(k) K800894

    The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / Ref / Catalog
5460-18-000, 546018000
Primary DI / UDI-DI
10603295174363
FDA Product Code
JDI
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3350
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Cleared under the same submission (K800894)

Show all (9)

Cleared under the same submission (K940743)

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

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