Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag
Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.
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 recall applies the 'risk-of-harm' criterion for medical devices without reported injury at the time of announcement. Hip implants are inherently high-risk devices, and a defect affecting component integrity could lead to device failure or revision surgery.
Plain-English summary
Exactech, Inc. has recalled certain Alteon Hip XLE Liner hip implant components due to loss of vacuum in the inner vacuum bag. The affected catalog numbers are 01-030-40-0636, 01-030-40-0640, and 01-030-42-0536. Exactech has received 3 complaints for 4 devices related to this defect.
Loss of vacuum in the inner-most vacuum bag may compromise the device component's structural integrity and long-term performance. The defect was identified through complaints received by the manufacturer.
The recalled devices were distributed in the United States in the following states: New York, Texas, Indiana, Illinois, Minnesota, Kentucky, Virginia, Maryland, Tennessee, Georgia, New Hampshire, Maine, South Carolina, Nevada, Florida, and Arkansas. Devices were also distributed internationally to Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom.
Patients who have received an affected implant should consult with their healthcare provider or surgeon about potential next steps. Healthcare providers can identify affected devices using the catalog numbers and specific serial numbers listed in the FDA recall notice and should report any adverse events related to the device to Exactech, Inc. or the FDA.
The recalled product
- Product
- Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
- Manufacturer
- Exactech, Inc.
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) 01-030-40-0636
- GTIN 10885862549655
- Serial Numbers: A678476
- A678485
- A678486
- A678495
- A678508
- A678516
- A678819
- A678820
- A678822
- A678826
- A678827
- A678832
- A678845
- A678847
- A678855
- A678859
- A678863
- b) 01-030-40-0640
Distribution
Part of a larger recall action
This product is one of 12 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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