ClearanceBrief
Recall Z-1182-03 ยท MNI Orthosis, Spinal Pedicle Fixation

U&I America

Optima Poly Screw Driver.

DateAug 27, 2003 (initiated Aug 18, 2003)
StatusTerminated
ReasonReports of pieces chipping off the tip of screwdriver during use.
Root causeOther
ActionConsignee was notified by letter on 8/18/2003
Quantity215 units.
DistributionMN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K020279FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
Forex Corp., Jun 20, 2002
K031585U&I, OPTIMA, SPINAL SYSTEM
U&I Corp., America, Jun 27, 2003