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Trident 621-00-28D

by Howmedica Osteonics Corp. EUDAMEDGUDID

Active European Union Open recall

Ref 621-00-28DModel 08858251002284SU

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002284SU Basic UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327037425 UDI-DIDate24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730291 Active Reissued

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    12 Jun 2026
    Expires
    21 Jun 2031
    Valid from
    22 Jun 2026

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-3204-2026 FDA Class II initiated 30 Jul 2026

    Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

    • Terminated Z-1043-2015 FDA Class II initiated 15 Dec 2014

    Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

  • 2 recalls, same reason

    • Terminated Z-0073-2008 FDA Unclassified (pre-2012) initiated 30 Aug 2007
    • Terminated Z-0072-2008 FDA Unclassified (pre-2012) initiated 30 Aug 2007

    Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

    • Terminated Z-1261-2007 FDA Unclassified (pre-2012) initiated 13 Mar 2006

    Dimensional anomaly

Specification

EUDAMED · GUDID

Trade Name
Trident® Crossfire® EUDAMED
Trident GUDID
Generic Name
Non-constrained polyethylene acetabular liner
Device Name
DD-013 - Trident Crossfire
Model / Ref / Catalog
621-00-28D, 08858251002284SU
Primary DI / UDI-DI
07613327037425
Basic UDI-DI
08858251002284SU
FDA Product Code
MEH, LPH
EMDN Code
P0908030499 Hip prostheses acetabular inserts - other
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3358
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 28.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K983382)

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Cleared under the same submission (K983502)

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Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

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

Other properties (19)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No