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Oxford® 32-423378

by Biomet Orthopedics, Inc.

Part of a family of 60 devices: see the family page

Ref 32-423378

Oxford® 32-423378 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024ALF22), cleared under FDA 510(k) K133940 on 28 Mar 2014 and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 00887868485800), active as of 7 Nov 2026. 4 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133940

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024ALF22 Basic UDI-DI 00887868485800UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868485800 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133940 Date28 Mar 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024ALF22 registered 30 Oct 2026 Active
  • FDA 510(k) K133940 decided 28 Mar 2014 Active
  • FDA GUDID UDI-DI 00887868485800 listed 2 Apr 2021 Listed

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.

Timeline

7 dated events

  1. Cleared FDA 510(k) K133940
  2. Recall initiated FDA recalls Z-0956-2017
  3. Recall initiated FDA recalls Z-2148-2020
  4. Recall initiated FDA recalls Z-0624-2021
  5. Listed FDA GUDID 00887868485800
  6. Recall initiated FDA recalls Z-1018-2023
  7. Registered EUDAMED 889024ALF22

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Oxford®
Generic name
Knee femur prosthesis trial, reusable
Device name
OFL Mono Bearing Trials
Model / Ref / Catalog
32-423378
Primary DI / UDI-DI
00887868485800
Basic UDI-DI
889024ALF22
Direct marketing DI
00887868485800
510(k) Number
FDA product code
HRY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Knee femur prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3530
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Knee femur prosthesis trial, reusable

Cleared under the same submission (K133940)

and 8 more cleared under K133940

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)