Skip to content

Na 201-90-01

by Exactech, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 10 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862046321 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

19 recalls · 10 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.

  • 3 recalls, same reason

    • Ongoing Z-0584-2024 FDA Class II initiated 21 Nov 2023
    • 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-0021-2022 FDA Class II initiated 30 Aug 2021

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

    • Ongoing Z-1364-2020 FDA Class II initiated 27 Jan 2020

    These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.

    • Ongoing Z-3209-2018 FDA Class II initiated 8 May 2018

    Potentially have non-conforming internal threads.

    • Terminated Z-2704-2017 FDA Class II initiated 7 Apr 2017

    Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

    • Terminated Z-0906-2015 FDA Class II initiated 9 Oct 2014

    Mislabeled

    • Terminated Z-0953-2013 FDA Class II initiated 1 Feb 2013

    A dimensional mismatch was identified which can potentially allow for interference between devices.

    • Terminated Z-2234-2012 FDA Class II initiated 17 Oct 2011

    Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic 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-2310-2012 FDA Class II initiated 19 Aug 2011

    Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

    • 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.

    • 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
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
201-90-01
Primary DI / UDI-DI
10885862046321
510(k) Number
FDA Product Code
JWH
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class II
Regulation Number
888.3560
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K011976)

Show all (12)

Cleared under the same submission (K033883)

Show all (12)

Cleared under the same submission (K071738)

Show all (12)

Cleared under the same submission (K093360)

Show all (12)

Cleared under the same submission (K101981)

Show all (12)

Cleared under the same submission (K110547)

Show all (12)

Cleared under the same submission (K111400)

Show all (12)

Cleared under the same submission (K121307)

Show all (12)

Cleared under the same submission (K123342)

Show all (12)

Cleared under the same submission (K132161)

Show all (12)

Cleared under the same submission (K150890)

Show all (12)

Cleared under the same submission (K932776)

Show all (10)

Cleared under the same submission (K933610)

Show all (12)

Cleared under the same submission (K954208)

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