ClearanceBrief
Recall Z-0558-04 ยท MNI Orthosis, Spinal Pedicle Fixation

U&I America

2.5mm Hex Driver

DateFeb 27, 2004 (initiated Jan 14, 2004)
StatusTerminated
ReasonReports of hex driver tips breaking off or becoming worn or stripped.
Root causeOther
ActionThe only consignee was notified by letter on 1/14/2003.
Quantity320 units
DistributionMN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K020279FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
Forex Corp., Jun 20, 2002
K024096OPTIMA, SPINAL SYSTEM
U&I Corp., America, Mar 12, 2003
K031585U&I, OPTIMA, SPINAL SYSTEM
U&I Corp., America, Jun 27, 2003
K031595U & I AMERICA SPINAL HOOK SYSTEM
U&I Corp., America, Jun 24, 2003