PlainRecalls
FDA Devices Moderate Class II Ongoing

Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

Reported: December 27, 2023 Initiated: November 21, 2023 #Z-0578-2024

Product Description

Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

Reason for Recall

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Details

Recalling Firm
Exactech, Inc.
Units Affected
N/A
Distribution
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
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536. Recalled by Exactech, Inc.. Units affected: N/A.
Why was this product recalled?
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 27, 2023. Severity: Moderate. Recall number: Z-0578-2024.