Skip to content

Vantage 351-10-17

by Exactech, Inc.

Vantage 351-10-17 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K152217 on 10 Mar 2016 and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862565655), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K152217

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862565655 UDI-DI Date28 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152217 Date10 Mar 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152217 decided 10 Mar 2016 Active
  • FDA GUDID UDI-DI 10885862565655 listed 28 Jul 2022 Listed

Recalls

6 recalls · 3 ongoing · FDA

    • Ongoing Z-0587-2024 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-0024-2022 FDA Class II initiated 30 Aug 2021

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

    • Ongoing Z-2926-2020 FDA Class II initiated 10 Aug 2020

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

    • Terminated Z-2966-2018 FDA Class II initiated 13 Jul 2018 on shared 510(k) K152217

    Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

  • 2 recalls, same reason

    • Terminated Z-0200-2018 FDA Class II initiated 16 May 2017
    • Terminated Z-0201-2018 FDA Class II initiated 16 May 2017

    Possible inner labeling and packaged device not matching the outer label on the box.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

8 dated events

  1. Cleared FDA 510(k) K152217
  2. Recall initiated FDA recalls Z-0200-2018
  3. Recall initiated FDA recalls Z-0201-2018
  4. Recall initiated FDA recalls Z-2966-2018
  5. Recall initiated FDA recalls Z-2926-2020
  6. Recall initiated FDA recalls Z-0024-2022
  7. Listed FDA GUDID 10885862565655
  8. Recall initiated FDA recalls Z-0587-2024

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vantage
Generic name
Osteotomy guide, reusable
Model / Ref / Catalog
351-10-17
Primary DI / UDI-DI
10885862565655
510(k) Number
FDA product code
HSN
GMDN term
Osteotomy guide, reusable
Device class
Class II
Regulation number
888.3110
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Osteotomy guide, reusable

Cleared under the same submission (K152217)

and 8 more cleared under K152217

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)