Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
FDA device recall Z-0584-2024 · posted 2024-01-18 · Open, Classified
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Action taken
- Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- JWH
- 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
- Date initiated
- 2023-11-21
- Date posted
- 2024-01-18
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI (K033883) | Exactech, Inc. | 2004-02-13 |