Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag

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.

Category

Medical Device — Orthopedic Implant / Hip Replacement

Hazard

• vacuum-loss
• implant-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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