ClearanceBrief
Recall Z-1438-04 ยท MNI Orthosis, Spinal Pedicle Fixation

U&I America

Optima Spinal System and Spinal Hook System, set screw component.

DateSep 8, 2004 (initiated Aug 10, 2004)
StatusTerminated
ReasonThreads on a set screw, as a component of a spinal fixation system, may break off during use.
Root causeOther
ActionConsignee was notified by letter on 08/10/2004.
Quantity200 set screws
DistributionCA
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