OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d)
FDA device recall Z-2158-2024 · posted 2024-06-18 · Open, Classified
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Action taken
- Exactech issued an URGENT VOLUNTARY MEDICAL DEVICE RECALL to its sales representatives on 04/12/2024. The notice explained the issue with the device, clinical impact (risk), and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form . The firm notified the surgeons, hospitals, and healthcare professionals on 04/18/2024. That notice also explained the issue, clinical impact (risk) and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Contact your Exactech Representative. Your local agent will help determine if you have any remaining affected product and remove from your inventory.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JWH
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-04-18
- Date posted
- 2024-06-18
- 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 Advanced Patella (K160484) | Exactech, Inc. | 2016-03-18 |
| EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY (K932690) | Exactech, Inc. | 1995-02-09 |
| EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS (K933610) | Exactech, Inc. | 1995-01-17 |