Device product
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Z-0584-2024
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 93507
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0584-2024
Official wording
Reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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
Derived failure modes
-
Unknown
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.