Exactech, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0578-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 21, 2023

Date Posted: December 27, 2023

Recall Number: Z-0578-2024

Event ID: 93507

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

Code Information:

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, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated