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Oxford Partial Knee System 159588

by Biomet Uk Ltd

Part of a family of 70 devices: see the family page

Ref 159588

Oxford Partial Knee System 159588 is a Class III device made by Biomet Uk Ltd, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 889024XKLE) with CE/MDR certificate MDR 754277 valid until 6 Nov 2027, approved under FDA PMA P010014 on 21 Apr 2004 and listed in FDA GUDID since 3 Sep 2014 (UDI-DI 05019279786343), active as of 25 Oct 2026. 14 FDA recalls are linked to it.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

6 Nov 2027

CE MDR certificate

FDA recalls

None ongoing

22 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P010014

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024XKLE Basic UDI-DI 05019279786343UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05019279786343 UDI-DI Date3 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP010014 Date21 Apr 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024XKLE registered 3 Sep 2026 Active· +1 more in the status table
  • FDA PMA P010014 decided 21 Apr 2004 Active
  • FDA GUDID UDI-DI 05019279786343 listed 3 Sep 2014 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 754277 Expiring Supplemented Expires in 359 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    11 Aug 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.

Timeline

27 dated events

  1. Recall initiated FDA recalls Z-1163-2017
  2. Recall initiated FDA recalls Z-1155-2017
  3. Recall initiated FDA recalls Z-1156-2017
  4. Recall initiated FDA recalls Z-1154-2017
  5. Recall initiated FDA recalls Z-1164-2017
  6. Recall initiated FDA recalls Z-1160-2017
  7. Recall initiated FDA recalls Z-1171-2017
  8. Certificate issued EUDAMED MDR 754277
  9. Registered EUDAMED 889024XKLE
  10. Certificate expires EUDAMED MDR 754277

17 earlier events are in the sections above.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Oxford Partial Knee System
Generic name
Unicondylar knee prosthesis
Device name
Oxford Anatomic Bearing Components
Model / Ref / Catalog
159588
Description
Anatomic Meniscal Bearing Right Medial
Primary DI / UDI-DI
05019279786343
Basic UDI-DI
889024XKLE
PMA number
FDA product code
NRA
EMDN code
P090904020201 Mobile unicompartmental knee prostheses tibial inserts
GMDN term
Unicondylar knee prosthesis
Device class
Class III
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Height — 9 Millimeter

Related devices

Category: Unicondylar knee prosthesis

Cleared under the same submission (P010014)

and 8 more cleared under P010014

Similar devices in this category

Other devices filed under UNICOMPARTMENTAL KNEE PROSTHESES (UNICONDYLAR).

Other devices from Biomet Uk Ltd

See all devices from Biomet Uk Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)