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Oxford® Partial Knee System 110110104

by Biomet Uk Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

22 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024682498 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Oxford® Partial Knee System
Generic Name
Unicondylar knee prosthesis
Model / Ref / Catalog
110110104
Primary DI / UDI-DI
00889024682498
PMA Number
FDA Product Code
NRA
GMDN Term
Unicondylar knee prosthesis
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Height — 4 Millimeter

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
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No