CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Vantage Ankle System recalled by Exactech
Exactech is recalling Vantage Ankle System, distributed in 16 states. The recall was initiated on 21 Nov 2023 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-0587-2024
- FDA event ID
- 93507
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Nov 2023
- FDA classified
- 19 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Nov 2023 | Recall initiated by company | |
| 19 Dec 2023 | Classified by FDA | +28 days |
| 27 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Product as listed by the FDA
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Where it was distributed
US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
ArkansasFloridaGeorgiaIllinoisIndianaKentuckyMarylandMaineMinnesotaNew HampshireNevadaNew YorkSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Which lots are affected?
a) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654
Where was it sold?
US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 93507This product is part of a recall event; the main page for the event is AcuMatch Hip System recalled by Exactech.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AcuMatch Hip System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Equinoxe Shoulder System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Equinoxe Reverse Shoulder System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Optetrak Logic PS Knee System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Novation Hip System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Alteon Hip XLE Liner recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Optetrak Knee System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Truliant Knee System recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Truliant, Activit-E Knee Insert recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Vantage Mobile Bearing Tibial Inserts recalled by Exactech | Exactech | Other | 16 states | |
| CLASS II | Optetrak Logic Knee System recalled by Exactech | Exactech | Other | 16 states |
More recalls from Exactech
All 197| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Equinoxe Core Instrument Kit recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Modular Impactor Handle recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Augments Pilot Tip Converter recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |