Recall Z-0181-2007 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
EBI, L.P.
VHS Pediatric Plate (for hip screw system) Ref 200501, VHS Pediatric Plate Stainless Steel Rx only, sterile
| Date | Nov 15, 2006 (initiated Sep 6, 2006) |
| Status | Terminated |
| Reason | VHS Plate and lag screw components did not assemble correctly intraoperatively. |
| Root cause | Other |
| Action | Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received. |
| Quantity | 363 in distributor inventory, 205 implanted, 352 plates in manufacturer's control |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011603 | VHS PEDIATRIC HIP SCREW SYSTEM Walter Abendschein, M.D., Aug 15, 2001 |