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Awl for humeral stem 72.02.20-14

by Zimmer, Inc. EUDAMEDGUDID

Active European Union

Ref 72.02.20-14

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024QVLF Basic UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024301863 UDI-DIDate24 Sep 2016ListedStatusListed 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  • Withdrawn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

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2003-2016 FDA Class II initiated 17 May 2016

    In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

Specification

EUDAMED · GUDID

Trade Name
Awl for humeral stem, 14 EUDAMED
Awl for humeral stem GUDID
Generic Name
Joint prosthesis implantation kit, reusable
Device Name
Anatomical Shoulder™ awl/reamer for humeral stem
Model / Ref / Catalog
72.02.20-14
Primary DI / UDI-DI
00889024301863
Basic UDI-DI
889024QVLF
Direct Marketing DI
00889024301863
510(k) Number
FDA Product Code
KWS, KWT, PHX, HSD
EMDN Code
P0901040201 Shoulder prostheses non modular stems
GMDN Term
Joint prosthesis implantation kit, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3660, 888.3650, 888.3690
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Joint prosthesis implantation kit, reusable

Cleared under the same submission (K142403)

Show all (12)

Other devices from Zimmer, Inc.

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Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No