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Oxford® Partial Knee System 154364

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number05019279515585 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-1018-2023 FDA Class II initiated 15 Dec 2022

    Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier

    • Terminated Z-0624-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-2148-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-0956-2017 FDA Class II initiated 6 Dec 2016

    Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing.

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  • Withdrawn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
154364
Primary DI / UDI-DI
05019279515585
510(k) Number
FDA Product Code
HRY
GMDN Term
Unicondylar knee prosthesis
Device Class
Class II
Regulation Number
888.3530
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Unicondylar knee prosthesis

Cleared under the same submission (K133940)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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

Other properties (7)

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