Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization a
FDA device recall Z-2059-2015 · posted 2015-07-10 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Incorrect thread form on the screw.
- Action taken
- Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 749 devices
- Distribution
- Distributed in the states of FL, GA, IL, NY, TX, and WA.
- Date initiated
- 2009-03-06
- Date posted
- 2015-07-10
- Date terminated
- 2015-07-14
- 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 |
|---|---|---|
| HYDRALOK SYSTEM (K051216) | Altiva Corp. | 2005-07-19 |