Recall archive / FDA device enforcement
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03 — FDA record Z-0588-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
- Reason
- Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Classification
- Class II
- Recalling firm
- Exactech, Inc.
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0588-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) 350-41-23, GTIN none, Serial Numbers: A658148; b) 350-42-03, GTIN none, Serial Numbers: A688867, A688880, A688864, A688868, A688870, A688872, A688873, A688876, A688879, A688881, A688882 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Nov 21, 2023
- Center classification date
- Dec 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.