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Na 231-04-02

by Exactech, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 7 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862062246 UDI-DIDate28 Jul 2022ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

9 recalls · 7 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2156-2024 FDA Class II initiated 18 Apr 2024
    • Ongoing Z-2155-2024 FDA Class II initiated 18 Apr 2024
    • Ongoing Z-2157-2024 FDA Class II initiated 18 Apr 2024
    • Ongoing Z-2158-2024 FDA Class II initiated 18 Apr 2024

    Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

  • 2 recalls, same reason

    • Ongoing Z-0583-2024 FDA Class II initiated 21 Nov 2023
    • Ongoing Z-0582-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    • Ongoing Z-0019-2022 FDA Class II initiated 30 Aug 2021

    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

    • Terminated Z-0927-06 FDA Unclassified (pre-2012) initiated 19 Dec 2005

    An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.

    • Terminated Z-1379-05 FDA Unclassified (pre-2012) initiated 2 Jun 2005

    Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.

Specification

GUDID

Trade Name
Na
Generic Name
Osteotomy guide, reusable
Model / Ref / Catalog
231-04-02
Primary DI / UDI-DI
10885862062246
510(k) Number
FDA Product Code
JWH
GMDN Term
Osteotomy guide, reusable
Device Class
Class II
Regulation Number
888.3560
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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