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Na 209-04-22

by Exactech, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862054746 UDI-DIDate18 Aug 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

34 recalls · FDA

  • 34 recalls, same reason

    • Terminated Z-0150-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0151-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0143-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0129-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0145-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0157-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0147-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0144-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0158-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0135-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0137-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0154-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0140-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0126-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0136-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0149-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0142-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0153-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0155-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0141-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0146-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0156-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0159-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0139-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0128-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0127-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0152-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0130-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0132-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0131-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0138-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0134-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0148-2018 FDA Class II initiated 19 Sep 2017
    • Terminated Z-0133-2018 FDA Class II initiated 19 Sep 2017

    There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Specification

GUDID

Trade Name
Na
Generic Name
Orthopaedic broach
Model / Ref / Catalog
209-04-22
Primary DI / UDI-DI
10885862054746
510(k) Number
FDA Product Code
JWH
GMDN Term
Orthopaedic broach
Device Class
Class II
Regulation Number
888.3560
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic broach

Cleared under the same submission (K023186)

Show all (12)

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

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