PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 27, 2023 Initiated: November 21, 2023 #Z-0584-2024

Product Description

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

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 Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009. 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-0584-2024.