Vantage Total Ankle System Recalled for Inadequate Packaging Barriers
Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall affects a load-bearing orthopedic implant. Although no injuries or illnesses have been reported, the inadequate oxygen barrier in packaging poses a risk of polyethylene degradation and potential device failure, satisfying the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Exactech, Inc. is recalling the Vantage Total Ankle System, including both the Fixed-Bearing Polyethylene Liner Component (Product Lines 350-21-XX and 350-22-XX) and the Mobile-Bearing Polyethylene Liner Component (Product Lines 350-41-XX and 350-42-XX). A total of 2,217 devices are affected by this recall.
The inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. This packaging defect allows oxygen to potentially penetrate over time, which could lead to oxidative degradation of the polyethylene components and compromise the long-term performance of the implant. No injuries or illnesses have been reported.
The affected devices were distributed worldwide, including throughout the United States and to approximately 40 countries including Canada, Mexico, Australia, Japan, and Great Britain. Healthcare providers who have implanted or stocked these devices should identify any affected units using the serial numbers provided in the FDA recall notice.
Patients who have received a Vantage Total Ankle System implant should contact their healthcare provider to determine if their device is affected. Healthcare facilities should stop using affected devices and contact Exactech for instructions regarding replacement or return. The complete list of affected serial numbers is available in FDA recall notice Z-0024-2022.
The recalled product
- Product
- Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall…
- Manufacturer
- Exactech, Inc.
- Affected units
- 2,217
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a. Item Number (Device Identifier
- Serial number(s)): 350-21-01 (10885862276216
- 4833710
- 4833714
- 4833715
- 4833717
- 4833723
- 5188005
- 5188007
- 5188008
- 5188009
- 5188011
- 5188013
- 5188015
- 5188017
- 5188021
- 5188022
- 5188023
- 5939820
- 5939826
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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