Exactech Vantage Ankle System Recalled Due to Vacuum Loss
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
What this means for you
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 is an FDA Class II recall affecting a surgical implant device with risk-of-harm potential. Although no illnesses, injuries, or deaths are reported in the source, the loss of vacuum represents a functional defect in a critical-use medical device, meeting the criterion for High severity.
Plain-English summary
Exactech, Inc. is recalling certain Vantage Ankle System devices with catalog numbers 350-21-04 and 350-22-03. The devices are identified by specific serial numbers and have been distributed throughout the United States and internationally.
The recall was initiated due to loss of vacuum in the inner-most vacuum bag of affected units. Exactech has received three complaints relating to this defect in four devices.
Healthcare providers and facilities using these devices should contact Exactech directly regarding the recall. Patients who have received these devices should consult with their healthcare provider about any necessary follow-up.
The recalled product
- Product
- Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
- Manufacturer
- Exactech, Inc.
- Hazard
- vacuum-loss
- device-malfunction
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 (17)
- 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
Distribution
Distributed in 16 states:
- AR
- FL
- GA
- IL
- IN
- KY
- MD
- ME
- MN
- NH
- NV
- NY
- SC
- TN
- TX
- VA
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