ClearanceBrief
Recall Z-0180-2007 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

EBI, L.P.

VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only

DateNov 15, 2006 (initiated Sep 6, 2006)
StatusTerminated
ReasonVHS Plate and lag screw components did not assemble correctly intraoperatively.
Root causeOther
ActionRecall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.
Quantity1117 in distributor inventory, 205 implanted, 1372 in manufacturer's control
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011603VHS PEDIATRIC HIP SCREW SYSTEM
Walter Abendschein, M.D., Aug 15, 2001