4mm Hex Driver
FDA device recall Z-0559-04 · posted 2004-02-27 · Terminated
Recall details
- Recalling firm
- U&I America
- Reason for recall
- Reports of hex driver tips breaking off or becoming worn or stripped.
- Action taken
- The only consignee was notified by letter on 1/14/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 300 units
- Distribution
- MN
- Date initiated
- 2004-01-14
- Date posted
- 2004-02-27
- Date terminated
- 2004-03-24
- Location
- Murray, UT
Monitor recalls programmatically
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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 |