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Na 201-57-21

by Exactech, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862043931 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

41 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

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

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

    • 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.

  • 34 recalls, same reason

    • 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-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
    • Terminated Z-0127-2018 FDA Class II initiated 19 Sep 2017
    • 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

    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.

    • Terminated Z-2070-2012 FDA Class II initiated 23 Sep 2011

    Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled.

    • Terminated Z-0347-05 FDA Unclassified (pre-2012) initiated 11 Nov 2004

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

Specification

GUDID

Trade Name
Na
Generic Name
Osteotomy guide, reusable
Model / Ref / Catalog
201-57-21
Primary DI / UDI-DI
10885862043931
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