Exactech, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0584-2024)

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 Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009

Product Classification:

Class II

Date Initiated: November 21, 2023

Date Posted: December 27, 2023

Recall Number: Z-0584-2024

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:

GTIN 10885862001924, Serial Numbers: A649282, A649289

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