Exactech, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0583-2024)

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 Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013

Product Classification:

Class II

Date Initiated: November 21, 2023

Date Posted: December 27, 2023

Recall Number: Z-0583-2024

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) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561

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