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Na 1363-08-000

by Depuy Orthopaedics, Inc. EUDAMEDGUDID

Active European Union Open recall

Ref 1363-08-000Model DEPUY SYNTHES Modular Cathcart Tapered Spacer 12/14 Taper

Regulatory status

as of 29 Oct 2026

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a004028E Basic UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295032663 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  • Withdrawn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 781955 Active Supplemented

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jul 2026
    Expires
    17 Aug 2030
    Reason
    Change approved

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1375-2022 FDA Class II initiated 18 May 2022

    The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.

Specification

EUDAMED · GUDID

Generic Name
Femoral head/stem prosthesis adaptor
Model / Ref / Catalog
1363-08-000, DEPUY SYNTHES Modular Cathcart Tapered Spacer 12/14 Taper, 136308000
Primary DI / UDI-DI
10603295032663
Basic UDI-DI
0603295a004028E
510(k) Number
FDA Product Code
LZY
EMDN Code
P090805 Hip prostheses spacers
GMDN Term
Femoral head/stem prosthesis adaptor
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3360
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Femoral head/stem prosthesis adaptor

Cleared under the same submission (K903084)

Show all (12)

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Manufacturing Date: No