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Oxford Fixed 32-423331

by Biomet Orthopedics, Inc.

Oxford Fixed 32-423331 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K122277 on 22 Oct 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00880304543508), active as of 23 Oct 2026. 30 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

30 closed

Documents

510(k) K122277

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304543508 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122277 Date22 Oct 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122277 decided 22 Oct 2012 Active
  • FDA GUDID UDI-DI 00880304543508 listed 21 Sep 2016 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

32 dated events

  1. Recall initiated FDA recalls Z-1707-2013
  2. Recall initiated FDA recalls Z-1710-2013
  3. Recall initiated FDA recalls Z-1700-2013
  4. Recall initiated FDA recalls Z-1719-2013
  5. Recall initiated FDA recalls Z-1695-2013
  6. Recall initiated FDA recalls Z-1705-2013
  7. Recall initiated FDA recalls Z-1714-2013
  8. Recall initiated FDA recalls Z-1699-2013
  9. Recall initiated FDA recalls Z-1721-2013
  10. Listed FDA GUDID 00880304543508

22 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Oxford Fixed
Generic name
Surgical implant template, reusable
Model / Ref / Catalog
32-423331
Primary DI / UDI-DI
00880304543508
510(k) Number
FDA product code
HRY
GMDN term
Surgical implant template, reusable
Device class
Class II
Regulation number
888.3530
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 Surgical implant template, reusable.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)