CLASS II Device recall · Reported 13 Dec 2017 · FDA Enforcement Report
Vantage Total Ankle Tibial Insert, Fixed Bearing, Left recalled
Exactech is recalling Vantage Total Ankle Tibial Insert, Fixed Bearing, Left, Size Exactech Inc. Intended for, distributed in North Carolina. The recall was initiated on 16 May 2017 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-0201-2018
- FDA event ID
- 77479
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2017
- FDA classified
- 6 Dec 2017
- Reported
- 13 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 16 May 2017 | Recall initiated by company | |
| 6 Dec 2017 | Classified by FDA | +204 days |
| 13 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible inner labeling and packaged device not matching the outer label on the box.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
Where it was distributed
Distributed in North Carolina
Questions about this recall
Is Vantage Total Ankle Tibial Insert, Fixed Bearing, Left, Size Exactech Inc. Intended for recalled?
Yes. Exactech recalled Vantage Total Ankle Tibial Insert, Fixed Bearing, Left, Size Exactech Inc. Intended for on 16 May 2017. The recall is Class II and its status is Terminated. Recall number Z-0201-2018.
Why was it recalled?
Possible inner labeling and packaged device not matching the outer label on the box.
Which lots are affected?
Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024
Where was it sold?
Distributed in North Carolina
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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Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |