Recall Z-1183-03 ยท MNI Orthosis, Spinal Pedicle Fixation
U&I America
Optima Large Poly Screw Driver
| Date | Aug 27, 2003 (initiated Aug 18, 2003) |
| Status | Terminated |
| Reason | Reports of pieces chipping off the tip of screwdriver during use. |
| Root cause | Other |
| Action | Consignee was notified by letter on 8/18/2003 |
| Quantity | 116 units. |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031585 | U&I, OPTIMA, SPINAL SYSTEM U&I Corp., America, Jun 27, 2003 |