ClearanceBrief
Recall Z-0659-03 ยท LXH Orthopedic Manual Surgical Instrument

Interpore Cross International Inc

TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.

DateMar 20, 2003 (initiated Feb 7, 2003)
StatusTerminated
ReasonInstrument fell apart during cleaning prior to surgery.
Root causeOther
ActionFirm telephoned customers on 2/7/2003 requesting that they immediately return thier instruments.
Quantity37 units
DistributionStates of NJ, CA, PA, MN, WI, MO, FL, OH, VA, MD, Wash DC, NY, CO, MA and to Brazil, Mexico, England, Denmark, Belgium, Australia.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.