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Oxford® Partial Knee System 113111600

by Biomet Uk Ltd

Ref 113111600

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

22 closed

Documents

None linked in EUDAMED

A group certificate may exist

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 Number889024-ZB003975-HY Basic UDI-DI 00889024683655UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024683655 UDI-DI Date3 Apr 2026ListedStatusListed GUDID: in commercial distribution

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

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
Knee tibia prosthesis trial, reusable
Device Name
Oxford Anatomic Tibia Templates
Model / Ref / Catalog
113111600
Primary DI / UDI-DI
00889024683655
Basic UDI-DI
889024-ZB003975-HY
PMA Number
FDA Product Code
NRA
EMDN Code
L091104 Orthopaedic prostheses positioners, reusable
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class I EUDAMED
Class III GUDID
EU 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 III

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

  • Reusable
  • CMR Substance
  • Prescription Use

Other properties (21)

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