CLASS II ONGOING Device recall · Reported 9 Sep 2020 · FDA Enforcement Report
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right recalled
Exactech is recalling The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right, distributed nationwide in the US. The recall was initiated on 10 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2926-2020
- FDA event ID
- 86261
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Aug 2020
- FDA classified
- 31 Aug 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 10 Aug 2020 | Recall initiated by company | |
| 31 Aug 2020 | Classified by FDA | +21 days |
| 9 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Where it was distributed
Domestic: CO,FL,OK, PA. International: Chile
Questions about this recall
Is The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right recalled?
Yes. Exactech recalled The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right on 10 Aug 2020. The recall is Class II and its status is Ongoing. Recall number Z-2926-2020.
Why was it recalled?
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.
Which lots are affected?
Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.
Where was it sold?
Domestic: CO,FL,OK, PA. International: Chile
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |