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Na 209-57-00

by Exactech, Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862056696 UDI-DIDate25 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

39 recalls · 4 ongoing · FDA

  • 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-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.

  • 34 recalls, same reason

    • 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-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
    • Terminated Z-0155-2018 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

    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-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.

Specification

GUDID

Trade Name
Na
Generic Name
Surgical screwdriver, reusable
Model / Ref / Catalog
209-57-00
Primary DI / UDI-DI
10885862056696
510(k) Number
FDA Product Code
JWH
GMDN Term
Surgical screwdriver, reusable
Device Class
Class II
Regulation Number
888.3560
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Width — 3.5 Millimeter

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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