Optima Spinal System and Spinal Hook System, set screw component.
FDA device recall Z-1438-04 · posted 2004-09-08 · Terminated
Recall details
- Recalling firm
- U&I America
- Reason for recall
- Threads on a set screw, as a component of a spinal fixation system, may break off during use.
- Action taken
- Consignee was notified by letter on 08/10/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 200 set screws
- Distribution
- CA
- Date initiated
- 2004-08-10
- Date posted
- 2004-09-08
- Date terminated
- 2005-11-29
- Location
- Murray, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| U&I, OPTIMA, SPINAL SYSTEM (K031585) | U&I Corp., America | 2003-06-27 |
| U & I AMERICA SPINAL HOOK SYSTEM (K031595) | U&I Corp., America | 2003-06-24 |
| OPTIMA, SPINAL SYSTEM (K024096) | U&I Corp., America | 2003-03-12 |
| FOREX CORPORATION, OPTIMA, SPINAL SYSTEM (K020279) | Forex Corp. | 2002-06-20 |