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Oxford® 32-423335

by Biomet Orthopedics, Inc.

Part of a family of 6 devices: see the family page

Ref 32-423335

Oxford® 32-423335 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 889024ALJ2A), cleared under FDA 510(k) K122277 on 22 Oct 2012 and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 00887868485534), active as of 7 Nov 2026. 30 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

None ongoing

30 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122277

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 Number889024ALJ2A Basic UDI-DI 00887868485534UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868485534 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122277 Date22 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024ALJ2A registered 30 Oct 2026 Active
  • FDA 510(k) K122277 decided 22 Oct 2012 Active
  • FDA GUDID UDI-DI 00887868485534 listed 2 Apr 2021 Listed

Recalls

30 recalls · FDA

  • 30 recalls, same reason

    • Terminated Z-1706-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1712-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1713-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1709-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1724-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1720-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1708-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1717-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1715-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1711-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1704-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1716-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1701-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1703-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1697-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1702-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1718-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1696-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1698-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1723-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1722-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1707-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1710-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1700-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1719-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1695-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1705-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1714-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1699-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1721-2013 FDA Class II initiated 7 Jun 2013

    Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Timeline

33 dated events

  1. Recall initiated FDA recalls Z-1710-2013
  2. Recall initiated FDA recalls Z-1700-2013
  3. Recall initiated FDA recalls Z-1719-2013
  4. Recall initiated FDA recalls Z-1695-2013
  5. Recall initiated FDA recalls Z-1705-2013
  6. Recall initiated FDA recalls Z-1714-2013
  7. Recall initiated FDA recalls Z-1699-2013
  8. Recall initiated FDA recalls Z-1721-2013
  9. Listed FDA GUDID 00887868485534
  10. Registered EUDAMED 889024ALJ2A

23 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 Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Oxford®
Generic name
Surgical implant template, reusable
Device name
OFL Tibial Templates
Model / Ref / Catalog
32-423335
Primary DI / UDI-DI
00887868485534
Basic UDI-DI
889024ALJ2A
Direct marketing DI
00887868485534
510(k) Number
FDA product code
HRY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical implant template, 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: Surgical implant template, reusable

Cleared under the same submission (K122277)

and 8 more cleared under K122277

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)