Optima Large Poly Screw Driver
FDA device recall Z-1183-03 · posted 2003-08-27 · Terminated
Recall details
- Recalling firm
- U&I America
- Reason for recall
- Reports of pieces chipping off the tip of screwdriver during use.
- Action taken
- Consignee was notified by letter on 8/18/2003
- Root cause
- Other
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 116 units.
- Distribution
- MN
- Date initiated
- 2003-08-18
- Date posted
- 2003-08-27
- Date terminated
- 2003-11-19
- 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 |