Exactech Vantage Total Ankle System

• • 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.

1. 10 Mar 2016 Cleared FDA 510(k) K152217
2. 16 May 2017 Recall initiated FDA recalls Z-0200-2018
3. 16 May 2017 Recall initiated FDA recalls Z-0201-2018
4. 13 Jul 2018 Recall initiated FDA recalls Z-2966-2018
5. 10 Aug 2020 Recall initiated FDA recalls Z-2926-2020
6. 30 Aug 2021 Recall initiated FDA recalls Z-0024-2022
7. 21 Nov 2023 Recall initiated FDA recalls Z-0587-2024

510(k) Number

K152217 ↗

FDA product code

HSN

Device class

Class II

Regulation

21 CFR Part 888.3110

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

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