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Oxford® Partial Knee System 112311400

by Biomet Uk Ltd

Ref 112311400

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

6 Nov 2027

CE MDR certificate

FDA recalls

None ongoing

22 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 754285 Date9 Sep 2026IssuedStatusActive expires 6 Nov 2027
United StatesGUDID listing GUDID Number00889024683358 UDI-DI Date3 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 754285 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    9 Sep 2026
    Expires
    6 Nov 2027
    Reason
    Other

Recalls

22 recalls · FDA

  • 20 recalls, same reason

    • Terminated Z-1153-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1168-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1162-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1152-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1159-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1170-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1165-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1173-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1158-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1172-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1161-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1169-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1157-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1163-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1155-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1156-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1154-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1164-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1160-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1171-2017 FDA Class II initiated 5 Jan 2016

    Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

    • Terminated Z-2698-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011 on shared PMA P010014

    This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.

    • Terminated Z-0962-2009 FDA Unclassified (pre-2012) initiated 19 Dec 2008

    Packages labeled as "right" actually contain a "left" component.

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

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade Name
Oxford® Partial Knee System
Generic Name
Unicondylar knee prosthesis
Device Name
Oxford Anatomic Cementless Tibia Tray
Model / Ref / Catalog
112311400
Primary DI / UDI-DI
00889024683358
Basic UDI-DI
889024-ZB003974-HV
PMA Number
FDA Product Code
NRA
EMDN Code
P090904020102 Mobile uncemented unicompartmental primary implant tibial plates
GMDN Term
Unicondylar knee prosthesis
Device Class
Class III
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (P010014)

Show all (12)

Other devices from Biomet Uk Ltd

See all devices from Biomet Uk Ltd →

Properties

  • Sterile
  • Implantable
  • CMR Substance
  • Prescription Use

Other properties (20)

  • Single Use: No
  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No